Manufacturers/Pfizer Inc.

Pfizer Inc.

118 drugs in NADAC|0 Generic,118 Brand

View Recalls (50)

Total Drugs

118

0G / 118B

Avg Price / Unit

$62.7336

$0.11 – $1810.40

Avg 7d Change

-0.03%

Across 14 drugs with changes

7d Activity

77104 flat

of 118 total drugs

Portfolio Price Trend

Monthly average NADAC price across all drugs

Drug Portfolio

118 drugs total, 118 shown

Drug Price 7d Change
GENOTROPIN 12 MG CARTRIDGE
somatropin
$1810.4035
per EA
GENOTROPIN 5 MG CARTRIDGE
somatropin
$748.3538
per EA
ESTRING 7.5 MCG/DAY (2 MG) RING
estradiol
$552.1545
per EA
INFLECTRA 100 MG VIAL
infliximab-dyyb
$491.5457
per EA
SUTENT 25 MG CAPSULE
Sunitinib malate
$449.0639
per EA
SUTENT 12.5 MG CAPSULE
Sunitinib malate
$222.4063
per EA
RETACRIT 20,000 UNIT/ML VIAL
epoetin alfa-epbx
$219.3906
per ML
XELJANZ XR 11 MG TABLET
tofacitinib
$207.7104
per EA
CIBINQO 100 MG TABLET
abrocitinib
$197.1952
per EA
ZAVZPRET 10 MG NASAL SPRAY
zavegepant
$190.1660
per EA
BICILLIN L-A 2,400,000 UNITS
penicillin G benzathine
$182.5544
per ML
PAXLOVID 300/150-100 MG DOSE PACK (SEVERE RENAL DOSE)
nirmatrelvir and ritonavir
$134.1575
per EA
PAXLOVID 300/150-100 MG DOSE PACK (SEVERE RENAL DOSE)
nirmatrelvir and ritonavir
$134.1575
per EA
NURTEC ODT 75 MG TABLET
rimegepant sulfate
$128.7461
per EA
RETACRIT 10,000 UNIT/ML VIAL
epoetin alfa-epbx
$109.9774
per ML
XELJANZ 10 MG TABLET
tofacitinib
$103.5456
per EA
GENOTROPIN MINIQUICK 0.6 MG
somatropin
$93.0500
per EA
VIAGRA 50 MG TABLET
sildenafil citrate
$84.5695
per EA
VIAGRA 50 MG TABLET
sildenafil citrate
$84.5695
per EA
VIAGRA 100 MG TABLET
sildenafil citrate
$83.6319
per EA
VIAGRA 100 MG TABLET
sildenafil citrate
$83.6319
per EA
BICILLIN L-A 1,200,000 UNITS
penicillin G benzathine
$76.5188
per ML
VIAGRA 25 MG TABLET
sildenafil citrate
$74.9876
per EA
XELJANZ 5 MG TABLET
tofacitinib
$73.8329
per EA
PAXLOVID 150-100 MG DOSE PACK (MODERATE RENAL DOSE)
nirmatrelvir and ritonavir
$73.7780
per EA
PAXLOVID 150-100 MG DOSE PACK (MODERATE RENAL DOSE)
nirmatrelvir and ritonavir
$73.7780
per EA
GENOTROPIN MINIQUICK 0.4 MG
somatropin
$61.6398
per EA
PAXLOVID 300-100 MG DOSE PACK
nirmatrelvir and ritonavir
$49.2992
per EA
PAXLOVID 300-100 MG DOSE PACK
nirmatrelvir and ritonavir
$49.2992
per EA
REVATIO 20 MG TABLET
sildenafil citrate
$46.6786
per EA
GENOTROPIN MINIQUICK 0.2 MG
somatropin
$30.8987
per EA
RETACRIT 2,000 UNIT/ML VIAL
epoetin alfa-epbx
$21.9820
per ML
LIPITOR 40 MG TABLET
atorvastatin calcium
$19.1970
per EA
CADUET 5 MG-80 MG TABLET
amlodipine besylate and atorvastatin calcium
$19.1510
per EA
NEURONTIN 800 MG TABLET
gabapentin
$16.8851
per EA
NEURONTIN 600 MG TABLET
gabapentin
$14.0827
per EA
EUCRISA 2% OINTMENT
crisaborole
$12.6464
per GM
-0.03%
NORVASC 10 MG TABLET
amlodipine besylate
$11.8615
per EA
TIKOSYN 500 MCG CAPSULE
dofetilide
$10.7711
per EA
TIKOSYN 500 MCG CAPSULE
dofetilide
$10.7711
per EA
EUCRISA 2% OINTMENT
crisaborole
$10.6810
per GM
0.00%
PROCARDIA XL 60 MG TABLET
nifedipine
$10.3797
per EA
PROCARDIA XL 60 MG TABLET
nifedipine
$10.3797
per EA
TIKOSYN 250 MCG CAPSULE
dofetilide
$9.9057
per EA
TIKOSYN 250 MCG CAPSULE
dofetilide
$9.9057
per EA
TIKOSYN 125 MCG CAPSULE
dofetilide
$9.8598
per EA
TIKOSYN 125 MCG CAPSULE
dofetilide
$9.8598
per EA
LYRICA 75 MG CAPSULE
PREGABALIN
$9.7349
per EA
+0.01%
LYRICA 75 MG CAPSULE
PREGABALIN
$9.7349
per EA
+0.01%
LYRICA 100 MG CAPSULE
PREGABALIN
$9.7025
per EA
LYRICA 100 MG CAPSULE
PREGABALIN
$9.6973
per EA
LYRICA 200 MG CAPSULE
PREGABALIN
$9.6962
per EA
-0.06%
LYRICA 300 MG CAPSULE
PREGABALIN
$9.6805
per EA
+0.01%
LYRICA 225 MG CAPSULE
PREGABALIN
$9.6742
per EA
-0.03%
TOVIAZ ER 8 MG TABLET
fesoterodine fumarate
$9.2714
per EA
+0.08%
OCTAGAM 10% (20 G/200 ML) VIAL
Immune Globulin
$9.2693
per ML
TOVIAZ ER 4 MG TABLET
fesoterodine fumarate
$9.2561
per EA
-0.04%
NEURONTIN 400 MG CAPSULE
gabapentin
$8.8672
per EA
NORVASC 2.5 MG TABLET
amlodipine besylate
$8.7038
per EA
NORVASC 5 MG TABLET
amlodipine besylate
$8.6824
per EA
NORVASC 5 MG TABLET
amlodipine besylate
$8.6824
per EA
ARTHROTEC 50 MG-200 MCG TAB
diclofenac sodium and misoprostol
$8.5495
per EA
ARTHROTEC 50 MG-200 MCG TAB
diclofenac sodium and misoprostol
$8.5495
per EA
ARTHROTEC 75 MG-200 MCG TAB
diclofenac sodium and misoprostol
$8.4959
per EA
-0.16%
CHANTIX 1 MG TABLET
varenicline tartrate
$8.0100
per EA
CHANTIX 0.5 MG TABLET
varenicline tartrate
$7.8518
per EA
DAYPRO 600 MG CAPLET
oxaprozin
$7.6370
per EA
NEURONTIN 300 MG CAPSULE
gabapentin
$7.3865
per EA
PROCARDIA XL 30 MG TABLET
nifedipine
$6.0506
per EA
PROCARDIA XL 30 MG TABLET
nifedipine
$6.0506
per EA
NORPACE CR 150 MG CAPSULE
disopyramide phosphate
$4.9062
per EA
CELONTIN 300 MG CAPSULE
methsuximide
$4.3993
per EA
NORPACE CR 100 MG CAPSULE
disopyramide phosphate
$4.1412
per EA
CYTOMEL 50 MCG TABLET
liothyronine sodium
$3.7012
per EA
MENEST 1.25 MG TABLET
esterified estrogens
$3.5806
per EA
LOMOTIL 2.5-0.025 MG TABLET
diphenoxylate hydrochloride and atropine sulfate
$3.0028
per EA
NEURONTIN 100 MG CAPSULE
gabapentin
$2.9576
per EA
NARDIL 15 MG TABLET
Phenelzine Sulfate
$2.5340
per EA
ALDACTONE 25 MG TABLET
spironolactone
$2.4713
per EA
MENEST 0.625 MG TABLET
esterified estrogens
$2.4046
per EA
ZITHROMAX 250 MG TABLET
azithromycin dihydrate
$2.0670
per EA
ZITHROMAX 250 MG TABLET
azithromycin dihydrate
$2.0670
per EA
ZITHROMAX 250 MG Z-PAK TABLET
azithromycin dihydrate
$2.0670
per EA
MENEST 0.3 MG TABLET
esterified estrogens
$1.8168
per EA
DILANTIN 100 MG CAPSULE
Extended Phenytoin Sodium
$1.7420
per EA
DILANTIN 50 MG INFATAB
Phenytoin
$1.5818
per EA
LEVOXYL 175 MCG TABLET
levothyroxine sodium
$1.3903
per EA
LEVOXYL 175 MCG TABLET
levothyroxine sodium
$1.3903
per EA
LEVOXYL 200 MCG TABLET
levothyroxine sodium
$1.3477
per EA
LEVOXYL 200 MCG TABLET
levothyroxine sodium
$1.3477
per EA
ZARONTIN 250 MG CAPSULE
Ethosuximide
$1.3086
per EA
LEVOXYL 150 MCG TABLET
levothyroxine sodium
$1.1694
per EA
LEVOXYL 150 MCG TABLET
levothyroxine sodium
$1.1694
per EA
LEVOXYL 137 MCG TABLET
levothyroxine sodium
$1.1503
per EA
LEVOXYL 137 MCG TABLET
levothyroxine sodium
$1.1503
per EA
LEVOXYL 125 MCG TABLET
levothyroxine sodium
$1.1347
per EA
LEVOXYL 125 MCG TABLET
levothyroxine sodium
$1.1347
per EA
LEVOXYL 112 MCG TABLET
levothyroxine sodium
$1.1175
per EA
LEVOXYL 112 MCG TABLET
levothyroxine sodium
$1.1175
per EA
LEVOXYL 100 MCG TABLET
levothyroxine sodium
$0.9682
per EA
LEVOXYL 100 MCG TABLET
levothyroxine sodium
$0.9682
per EA
LEVOXYL 88 MCG TABLET
levothyroxine sodium
$0.9605
per EA
LEVOXYL 88 MCG TABLET
levothyroxine sodium
$0.9605
per EA
LEVOXYL 75 MCG TABLET
levothyroxine sodium
$0.9440
per EA
LEVOXYL 75 MCG TABLET
levothyroxine sodium
$0.9440
per EA
LEVOXYL 50 MCG TABLET
levothyroxine sodium
$0.8527
per EA
LEVOXYL 50 MCG TABLET
levothyroxine sodium
$0.8527
per EA
LEVOXYL 25 MCG TABLET
levothyroxine sodium
$0.7527
per EA
LEVOXYL 25 MCG TABLET
levothyroxine sodium
$0.7527
per EA
NITROSTAT 0.3 MG TABLET SL
nitroglycerin
$0.5513
per EA
CYTOMEL 25 MCG TABLET
liothyronine sodium
$0.5360
per EA
SILVADENE 1% CREAM
silver sulfadiazine
$0.4333
per GM
+0.03%
CYTOMEL 5 MCG TABLET
liothyronine sodium
$0.3862
per EA
SILVADENE 1% CREAM
silver sulfadiazine
$0.2629
per GM
SILVADENE 1% CREAM
silver sulfadiazine
$0.2546
per GM
+0.42%
SILVADENE 1% CREAM
silver sulfadiazine
$0.2299
per GM
-0.36%
SILVADENE 1% CREAM
silver sulfadiazine
$0.2299
per GM
-0.36%
SILVADENE 1% CREAM
silver sulfadiazine
$0.1099
per GM
+0.04%

FDA Recalls (50)

Recalls matched by company name. Verify current status with FDA.

D-0545-2025
Ongoing
Class II

Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04

CGMP Deviations; particulates identified during visual inspection

Initiated: 7/10/2025
D-0544-2025
Ongoing
Class II

Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-701-02

CGMP Deviations; particulates identified during visual inspection

Initiated: 7/10/2025
D-0489-2025
Ongoing
Class II

DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC Carton: 0409-2344-02; NDC Vial: 0409-2344-62

Discoloration; discolored solution from cracked vials

Initiated: 5/28/2025
D-0564-2024
Ongoing
Class II

Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2012-03

Lack of Assurance of Sterility-The potential for incomplete crimp seals.

Initiated: 5/20/2024
D-0565-2024
Ongoing
Class II

Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2339-24

Lack of Assurance of Sterility-The potential for incomplete crimp seals.

Initiated: 5/20/2024
D-0233-2024
Ongoing
Class I

4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton), 0409-5534-14 (case).

Presence of Particulate Matter; identified as glass

Initiated: 12/21/2023
D-0234-2024
Ongoing
Class I

8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL Syringe per Carton, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6637-24 (carton), 0409-6637-14 (case).

Presence of Particulate Matter; identified as glass

Initiated: 12/21/2023
D-0235-2024
Ongoing
Class I

Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake FOrest, IL 60045, NDC 0409-4911-11 (carton), 0409-4911-34 (case).

Presence of Particulate Matter; identified as glass

Initiated: 12/21/2023
D-0101-2024
Terminated
Class I

1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4904-11

Presence of Particulate Matter: identified as glass.

Initiated: 10/2/2023
D-0100-2024
Terminated
Class I

4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24

Presence of Particulate Matter: identified as glass.

Initiated: 10/2/2023
D-0102-2024
Terminated
Class I

2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4903-11

Presence of Particulate Matter: identified as glass.

Initiated: 10/2/2023
D-0532-2023
Ongoing
Class III

MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc., Boulder, CO 80301. NDC: 70255-010-02

Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.

Initiated: 3/8/2023
D-0097-2023
Completed
Class II

Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,

Lack of assurance of sterility: Bags have the potential to leak.

Initiated: 12/29/2022
D-0184-2023
Terminated
Class I

Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0409-3515-01

Presence of Particulate Matter: Glass particulate matter detected in injectable.

Initiated: 12/22/2022
D-0003-2023
Terminated
Class II

Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. NDC 0409-5921-16 (vial) 0409-5921-01 (carton)

Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.

Initiated: 9/27/2022
D-1540-2022
Terminated
Class I

PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Presence of particulate matter

Initiated: 8/22/2022
D-1301-2022
Terminated
Class I

Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Presence of particulate matter: particulate identified as a beetle.

Initiated: 7/13/2022
D-0874-2022
Terminated
Class II

Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017

CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.

Initiated: 4/22/2022
D-0873-2022
Terminated
Class II

Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017

CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.

Initiated: 4/22/2022
D-0872-2022
Terminated
Class II

Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017

CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.

Initiated: 4/22/2022
D-0756-2022
Terminated
Class II

Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles, Rx Only Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0220-23.

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Initiated: 3/21/2022
D-0760-2022
Terminated
Class II

quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0223-1

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Initiated: 3/21/2022
D-0758-2022
Terminated
Class II

quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-5225-9

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Initiated: 3/21/2022
D-0759-2022
Terminated
Class II

quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0220-1

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Initiated: 3/21/2022
D-0754-2022
Terminated
Class II

Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-3112-23.

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Initiated: 3/21/2022
D-0755-2022
Terminated
Class II

Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0222-23

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Initiated: 3/21/2022
D-0757-2022
Terminated
Class II

Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0223-23.

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Initiated: 3/21/2022
D-0761-2022
Terminated
Class II

Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY. NY 10017, Made in Germany, NDC 0071-5212-23 .

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Initiated: 3/21/2022
D-0265-2022
Terminated
Class II

5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66

Lack of sterility assurance: bag has the potential to leak.

Initiated: 11/30/2021
D-0809-2021
Ongoing
Class II

Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0468-56.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Initiated: 8/13/2021
D-0808-2021
Ongoing
Class II

Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42.1 mg tablets.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Initiated: 8/13/2021
D-0810-2021
Ongoing
Class II

Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-56.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Initiated: 8/13/2021
D-0811-2021
Ongoing
Class II

Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE: September 2021 June 2023

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Initiated: 8/13/2021
D-0701-2021
Ongoing
Class II

Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0469-56

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

Initiated: 6/9/2021
D-0700-2021
Ongoing
Class II

Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069-0471-03.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

Initiated: 6/9/2021
D-0699-2021
Ongoing
Class II

Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0468-56

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Initiated: 6/9/2021
D-0384-2021
Terminated
Class II

Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25

Presence of Particulate Matter: particulate matter identified as an insect in one vial.

Initiated: 5/3/2021
D-1446-2020
Terminated
Class II

Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12

Lack of Assurance of Sterility; potential loose metal overseal crimp defects.

Initiated: 7/20/2020
D-1306-2020
Terminated
Class II

Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, carton NDC 0049-0013-83

Presence of Particulate Matter: particulate matter identified after reconstitution.

Initiated: 5/29/2020
D-1342-2020
Terminated
Class III

Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx Only, Distributed by Wyeth Pharmaceuticals LLC A subsidiary of Pfizer In Philadelphia, PA 19101 Made in Ireland, NDC 00008-1123-12

Failed Dissolution Specifications

Initiated: 5/27/2020
D-0995-2020
Terminated
Class II

Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. NDC 0069-0106-01

Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.

Initiated: 2/27/2020
D-0841-2020
Terminated
Class II

Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2180-30.

Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.

Initiated: 2/5/2020
D-0842-2020
Terminated
Class II

Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2160-30.

Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.

Initiated: 2/5/2020
D-0835-2020
Terminated
Class II

Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray).

Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.

Initiated: 2/3/2020
D-0577-2020
Terminated
Class II

25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1775-10

Labeling: Incorrect or Missing Lot and/or expiration date.

Initiated: 11/27/2019
D-0136-2020
Terminated
Class II

10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7418-13

Lack of Assurance of Sterility: Bag has the potential to leak.

Initiated: 10/2/2019
D-0001-2020
Terminated
Class III

ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone LLC Peapack, NJ 07977 Made in Netherlands. NDC 59762-2250-2

Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.

Initiated: 9/12/2019
D-0002-2020
Terminated
Class III

Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in Netherlands Distributed by Parke-Davis Division of Pfizer In NY, NY 10017, NDC 0071-0237-24

Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.

Initiated: 9/12/2019
D-1852-2019
Terminated
Class II

Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01; NDC Carton: 0409-3977-03

Lack of Assurance of Sterility

Initiated: 9/6/2019
D-1845-2019
Terminated
Class II

RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12-count (2 cards x 6 tablets) per carton, NDC 0049-2340-05, Rx only, Made in Ireland, Distributed by Pfizer Roerig, Division of Pfizer Inc., NY, NY 10017.

Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.

Initiated: 8/14/2019