Manufacturers/Mylan Institutional LLC

Mylan Institutional LLC

149 drugs in NADAC|147 Generic,2 Brand

View Recalls (15)

Mylan Institutional LLC lists 149 NDCs in the CMS NADAC file (147 generic, 2 brand), at an average NADAC of $25.25 per unit, with a week-over-week move of +0.2% across products that moved. The firm's full portfolio, pricing trend, and FDA recalls are listed below.

Total Drugs

149

147G / 2B

Avg Price / Unit

$25.2453

$0.02 – $3185.94

Avg 7d Change

+0.23%

Across 117 drugs with changes

7d Activity

59↑58↓32 flat

of 149 total drugs

Portfolio Price Trend

Monthly average NADAC price across all drugs

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Frequently Asked Questions

How many drugs does Mylan Institutional LLC make?

Mylan Institutional LLC lists 149 NDCs in the CMS NADAC file — 147 generic and 2 brand products.

What is the average price of Mylan Institutional LLC drugs?

The average NADAC across Mylan Institutional LLC's portfolio is $25.2453 per unit, ranging from $0.0159 to $3185.9367.

What types of drugs does Mylan Institutional LLC make?

Mylan Institutional LLC makes drugs across 51 FDA pharmacologic classes. The most common by NDC count are Corticosteroid (11), l-Thyroxine (10), Phenothiazine (9), Typical Antipsychotic (8), HMG-CoA Reductase Inhibitor (6).

Has Mylan Institutional LLC had any drug recalls?

15 FDA recalls are matched to Mylan Institutional LLC in the openFDA feed, most recently on May 3, 2021.

How has Mylan Institutional LLC's pricing changed recently?

Over the past 7 days, 59 Mylan Institutional LLC products rose and 58 fell, with a portfolio-wide average change of +0.2%.

Drug Portfolio

149 drugs total, 149 shown

Drug ↕Price 7d Change ↕
FULPHILA 6 MG/0.6 ML SYRINGE
pegfilgrastim
$3185.9367
per ML
—
FONDAPARINUX 5 MG/0.4 ML SYR
fondaparinux sodium
$55.3125
per ML
—
IBANDRONATE 3 MG/3 ML SYRINGE
ibandronate sodium
$54.2117
per ML
—
FONDAPARINUX 10 MG/0.8 ML SYR
fondaparinux sodium
$44.8161
per ML
-2.64%
FONDAPARINUX 7.5 MG/0.6 ML SYR
fondaparinux sodium
$42.8089
per ML
+0.23%
VANCOMYCIN HCL 5 GM VIAL
vancomycin hydrochloride
$39.3160
per EA
—
FOSAPREPITANT 150 MG VIAL
fosaprepitant
$38.5080
per EA
—
VANCOMYCIN HCL 10 GM VIAL
Vancomycin Hydrochloride
$35.8586
per EA
—
DAPTOMYCIN 500 MG VIAL
daptomycin
$23.7984
per EA
+4.90%
DAPTOMYCIN 500 MG VIAL
daptomycin
$23.7984
per EA
+4.90%
MEDROXYPROGESTERONE 150 MG/ML
Medroxyprogesterone Acetate
$22.8495
per ML
—
FONDAPARINUX 2.5 MG/0.5 ML SYR
fondaparinux sodium
$22.1623
per ML
—
MEDROXYPROGESTERONE 150 MG/ML
Medroxyprogesterone Acetate
$18.3134
per ML
—
NALOXONE 4 MG/10 ML VIAL
naloxone hydrochloride
$15.7839
per ML
—
HALOPERIDOL DEC 100 MG/ML VIAL
Haloperidol Decanoate
$15.5981
per ML
+8.90%
NALOXONE 4 MG/10 ML VIAL
naloxone hydrochloride
$11.2094
per ML
—
FLUPHENAZINE DEC 125 MG/5 ML
FLUPHENAZINE DECANOATE
$10.8440
per ML
-0.44%
HALOPERIDOL DEC 50 MG/ML VIAL
Haloperidol Decanoate
$6.5723
per ML
-2.48%
TRIAMCINOLONE ACET 200 MG/5 ML
TRIAMCINOLONE ACETONIDE
$6.3832
per ML
+0.87%
B-COMPLEX 100 INJECTION
thiamine hydrochloride, riboflavin 5 phosphate sodium, dexpanthenol and niacinamide
$6.1199
per ML
—
TRIAMCINOLONE ACET 40 MG/ML VL
TRIAMCINOLONE ACETONIDE
$4.8304
per ML
-0.16%
TRIAMCINOLONE ACET 400 MG/10 ML
TRIAMCINOLONE ACETONIDE
$4.7820
per ML
-1.79%
ZOLEDRONIC ACID 4 MG/5 ML VIAL
Zoledronic acid
$4.6828
per ML
—
CLOZAPINE ODT 100 MG TABLET
clozapine
$4.2646
per EA
+0.31%
NALOXONE 0.4 MG/ML VIAL
naloxone hydrochloride
$4.0147
per ML
—
NALOXONE 0.4 MG/ML VIAL
naloxone hydrochloride
$3.8243
per ML
-4.74%
ISONIAZID 300 MG TABLET
Isoniazid
$3.4020
per EA
-2.57%
VANCOMYCIN 1 GM VIAL
Vancomycin Hydrochloride
$2.9591
per EA
—
VERAPAMIL ER 120 MG CAPSULE
verapamil hydrochloride
$2.7493
per EA
+17.97%
IMATINIB MESYLATE 400 MG TAB
imatinib
$2.6771
per EA
-6.93%
VANCOMYCIN 500 MG VIAL
Vancomycin Hydrochloride
$2.3054
per EA
—
HEPARIN SODIUM 10,000 UNIT/ML VIAL
Heparin Sodium
$2.2868
per ML
—
THIAMINE 200 MG/2 ML VIAL
thiamine hydrochloride
$2.2468
per ML
+3.90%
DILTIAZEM 12HR ER 120 MG CAP
diltiazem hydrochloride
$1.9704
per EA
-0.46%
VORICONAZOLE 200 MG TABLET
voriconazole
$1.8846
per EA
+4.60%
RIMSO-50 SOLUTION
Dimethyl Sulfoxide
$1.7675
per ML
—
DILTIAZEM 12HR ER 90 MG CAP
diltiazem hydrochloride
$1.6614
per EA
-7.66%
DILTIAZEM 12HR ER 60 MG CAP
diltiazem hydrochloride
$1.4266
per EA
-5.65%
TRIFLUOPERAZINE 10 MG TABLET
trifluoperazine hydrochloride
$1.2432
per EA
+0.48%
POLYETHYLENE GLYCOL 3350 POWD
polyethylene glycol (3350)
$1.2244
per EA
+6.04%
HEPARIN SODIUM 5,000 UNIT/ML VIAL
Heparin Sodium
$1.2024
per ML
—
CLOZAPINE 200 MG TABLET
clozapine
$0.9689
per EA
+5.77%
TRIFLUOPERAZINE 5 MG TABLET
trifluoperazine hydrochloride
$0.8600
per EA
-7.54%
TOBRAMYCIN 80 MG/2 ML VIAL
Tobramycin
$0.8315
per ML
+12.45%
THIORIDAZINE 100 MG TABLET
thioridazine hydrochloride
$0.8303
per EA
+3.48%
VORICONAZOLE 50 MG TABLET
voriconazole
$0.8275
per EA
+17.44%
DIPHENHYDRAMINE 500 MG/10 ML VL
diphenhydramine hydrochloride
$0.7900
per ML
—
HALOPERIDOL LAC 5 MG/ML VIAL
HALOPERIDOL LACTATE
$0.7820
per ML
-0.88%
THIORIDAZINE 50 MG TABLET
thioridazine hydrochloride
$0.7220
per EA
-3.63%
TACROLIMUS 5 MG CAPSULE (IMMEDIATE RELEASE)
Tacrolimus
$0.6881
per EA
+4.39%
DEXAMETHASONE 4 MG/ML VIAL
Dexamethasone Sodium Phosphate
$0.6735
per ML
+0.24%
DEXAMETHASONE 4 MG/ML VIAL
Dexamethasone Sodium Phosphate
$0.6735
per ML
+0.24%
IMATINIB MESYLATE 100 MG TAB
imatinib
$0.6243
per EA
+2.12%
CLOZAPINE 100 MG TABLET
clozapine
$0.6103
per EA
+0.45%
TRIFLUOPERAZINE 2 MG TABLET
trifluoperazine hydrochloride
$0.5787
per EA
-3.16%
THIORIDAZINE 25 MG TABLET
thioridazine hydrochloride
$0.5713
per EA
-0.10%
ABACAVIR 300 MG TABLET
abacavir sulfate
$0.5455
per EA
+1.40%
DEXAMETHASONE 100 MG/10 ML VL
Dexamethasone Sodium Phosphate
$0.5104
per ML
+1.23%
DEXAMETHASONE 100 MG/10 ML VL
Dexamethasone Sodium Phosphate
$0.5104
per ML
+1.23%
CYANOCOBALAMIN 30,000 MCG/30 ML
cyanocobalamine
$0.4930
per ML
—
SPIRONOLACTONE-HYDROCHLOROTHIAZIDE 25-25 TAB
spironolactone and hydrochlorothiazide
$0.4833
per EA
-2.58%
ZOLEDRONIC ACID 5 MG/100 ML
Zoledronic Acid
$0.4751
per ML
-0.48%
TRIFLUOPERAZINE 1 MG TABLET
trifluoperazine hydrochloride
$0.4251
per EA
-2.44%
TRANEXAMIC ACID 1,000 MG/10 ML
tranexamic acid
$0.4035
per ML
+4.32%
ROCURONIUM 50 MG/5 ML VIAL
rocuronium bromide
$0.3942
per ML
—
THIORIDAZINE 10 MG TABLET
thioridazine hydrochloride
$0.3939
per EA
+3.11%
DOXEPIN 100 MG CAPSULE
doxepin hydrochloride
$0.2901
per EA
+8.71%
MYCOPHENOLATE 500 MG TABLET
mycophenolate mofetil
$0.2725
per EA
—
CLOZAPINE 25 MG TABLET
clozapine
$0.2424
per EA
-5.08%
METOLAZONE 5 MG TABLET
metolazone
$0.2392
per EA
-9.50%
DEXAMETHASONE 20 MG/5 ML VIAL
Dexamethasone Sodium Phosphate
$0.2381
per ML
—
DEXAMETHASONE 20 MG/5 ML VIAL
Dexamethasone Sodium Phosphate
$0.2381
per ML
—
METOLAZONE 2.5 MG TABLET
metolazone
$0.2328
per EA
+2.15%
VALACYCLOVIR HCL 500 MG TABLET
valacyclovir hydrochloride
$0.2289
per EA
+2.17%
DEXAMETHASONE 120 MG/30 ML VL
Dexamethasone Sodium Phosphate
$0.2276
per ML
—
DEXAMETHASONE 120 MG/30 ML VL
Dexamethasone Sodium Phosphate
$0.2276
per ML
—
DIVALPROEX SOD ER 500 MG TAB
divalproex sodium
$0.1943
per EA
+5.83%
HALOPERIDOL 5 MG TABLET
haloperidol
$0.1807
per EA
+1.40%
CARBIDOPA-LEVO ER 50-200 TAB
carbidopa and levodopa
$0.1796
per EA
+3.52%
SUCRALFATE 1 GM TABLET
Sucralfate
$0.1727
per EA
+0.13%
SPIRONOLACTONE 100 MG TABLET
spironolactone
$0.1678
per EA
-1.22%
HALOPERIDOL 2 MG TABLET
haloperidol
$0.1658
per EA
+5.00%
HALOPERIDOL 10 MG TABLET
haloperidol
$0.1641
per EA
—
CHLORDIAZEPOXIDE 25 MG CAPSULE
Chlordiazepoxide Hydrochloride
$0.1582
per EA
-1.09%
METHOTREXATE 2.5 MG TABLET
methotrexate
$0.1577
per EA
+0.74%
DOXEPIN 50 MG CAPSULE
doxepin hydrochloride
$0.1571
per EA
+2.40%
TACROLIMUS 1 MG CAPSULE (IMMEDIATE RELEASE)
Tacrolimus
$0.1535
per EA
+1.12%
CHLORDIAZEPOXIDE 10 MG CAPSULE
Chlordiazepoxide Hydrochloride
$0.1435
per EA
+0.20%
DOXEPIN 25 MG CAPSULE
doxepin hydrochloride
$0.1415
per EA
+3.45%
PRAZOSIN 5 MG CAPSULE
prazosin hydrochloride
$0.1337
per EA
+3.42%
DIVALPROEX SOD ER 250 MG TAB
divalproex sodium
$0.1298
per EA
+0.86%
TACROLIMUS 0.5 MG CAPSULE (IMMEDIATE RELEASE)
Tacrolimus
$0.1227
per EA
-2.25%
BUSPIRONE HCL 30 MG TABLET
buspirone hydrochloride
$0.1198
per EA
+1.01%
FENOFIBRATE 145 MG TABLET
fenofibrate
$0.1196
per EA
-1.50%
HALOPERIDOL 1 MG TABLET
haloperidol
$0.1195
per EA
+0.71%
MIDODRINE HCL 5 MG TABLET
midodrine hydrochloride
$0.1113
per EA
-1.88%
MIRTAZAPINE 45 MG TABLET
Mirtazapine
$0.1108
per EA
+5.40%
CARBIDOPA-LEVO ER 25-100 TAB
carbidopa and levodopa
$0.1101
per EA
-3.09%
LANSOPRAZOLE DR 30 MG CAPSULE
lansoprazole
$0.1061
per EA
-0.89%
MIRTAZAPINE 30 MG TABLET
Mirtazapine
$0.0885
per EA
+1.89%
PRAZOSIN 2 MG CAPSULE
prazosin hydrochloride
$0.0863
per EA
+1.60%
HALOPERIDOL 0.5 MG TABLET
haloperidol
$0.0857
per EA
-8.72%
PRAVASTATIN SODIUM 40 MG TAB
Pravastatin Sodium
$0.0848
per EA
—
PRAZOSIN 1 MG CAPSULE
prazosin hydrochloride
$0.0842
per EA
-1.92%
SPIRONOLACTONE 50 MG TABLET
spironolactone
$0.0832
per EA
-1.68%
METOPROLOL SUCC ER 100 MG TAB
metoprolol succinate
$0.0822
per EA
—
FENOFIBRATE 48 MG TABLET
fenofibrate
$0.0794
per EA
-2.46%
DOXEPIN 10 MG CAPSULE
doxepin hydrochloride
$0.0779
per EA
+0.36%
CHLORTHALIDONE 25 MG TABLET
chlorthalidone
$0.0743
per EA
-11.48%
LEVETIRACETAM 500 MG TABLET
levetiracetam
$0.0736
per EA
-0.39%
LEVOTHYROXINE 175 MCG TABLET
levothyroxine sodium
$0.0735
per EA
-4.01%
ATORVASTATIN 80 MG TABLET
atorvastatin calcium
$0.0693
per EA
+0.03%
LEVOTHYROXINE 137 MCG TABLET
levothyroxine sodium
$0.0639
per EA
+1.83%
MIRTAZAPINE 15 MG TABLET
Mirtazapine
$0.0630
per EA
-2.40%
PRAVASTATIN SODIUM 20 MG TAB
Pravastatin Sodium
$0.0620
per EA
—
CETIRIZINE HCL 10 MG TABLET
cetirizine hydrochloride
$0.0613
per EA
-2.62%
LEVOTHYROXINE 112 MCG TABLET
levothyroxine sodium
$0.0588
per EA
-0.25%
LEVOTHYROXINE 150 MCG TABLET
levothyroxine sodium
$0.0586
per EA
-1.84%
LEVOTHYROXINE 125 MCG TABLET
levothyroxine sodium
$0.0570
per EA
-0.02%
LOPERAMIDE 2 MG CAPSULE
loperamide hydrochloride
$0.0549
per EA
-2.81%
LORATADINE 10 MG TABLET
loratadine
$0.0529
per EA
-0.40%
ALLOPURINOL 300 MG TABLET
allopurinol
$0.0522
per EA
-4.50%
LEVOTHYROXINE 100 MCG TABLET
levothyroxine sodium
$0.0497
per EA
-1.99%
LEVOTHYROXINE 88 MCG TABLET
levothyroxine sodium
$0.0495
per EA
-1.36%
LEVOTHYROXINE 75 MCG TABLET
levothyroxine sodium
$0.0461
per EA
-0.45%
HYDRALAZINE 50 MG TABLET
Hydralazine Hydrochloride
$0.0445
per EA
-2.13%
METOCLOPRAMIDE 10 MG TABLET
Metoclopramide
$0.0439
per EA
+0.25%
BUSPIRONE HCL 15 MG TABLET
buspirone hydrochloride
$0.0430
per EA
+1.54%
SPIRONOLACTONE 25 MG TABLET
spironolactone
$0.0426
per EA
-0.91%
LEVOTHYROXINE 50 MCG TABLET
levothyroxine sodium
$0.0407
per EA
+0.27%
ATORVASTATIN 40 MG TABLET
atorvastatin calcium
$0.0374
per EA
+1.05%
ATENOLOL 100 MG TABLET
atenolol
$0.0361
per EA
-2.38%
METOCLOPRAMIDE 5 MG TABLET
Metoclopramide
$0.0358
per EA
+1.10%
PANTOPRAZOLE SOD DR 40 MG TAB
pantoprazole sodium
$0.0358
per EA
+1.56%
HYDRALAZINE 25 MG TABLET
Hydralazine Hydrochloride
$0.0357
per EA
+0.37%
LEVOTHYROXINE 25 MCG TABLET
levothyroxine sodium
$0.0351
per EA
-1.74%
ALLOPURINOL 100 MG TABLET
allopurinol
$0.0315
per EA
-0.50%
DIAZEPAM 10 MG TABLET
diazepam
$0.0283
per EA
-2.55%
BUSPIRONE HCL 10 MG TABLET
buspirone hydrochloride
$0.0279
per EA
—
ATORVASTATIN 20 MG TABLET
atorvastatin calcium
$0.0279
per EA
+1.09%
DIAZEPAM 5 MG TABLET
diazepam
$0.0276
per EA
-3.80%
HYDRALAZINE 10 MG TABLET
Hydralazine Hydrochloride
$0.0270
per EA
-0.33%
ATENOLOL 50 MG TABLET
atenolol
$0.0236
per EA
-0.76%
ATORVASTATIN 10 MG TABLET
atorvastatin calcium
$0.0228
per EA
-1.81%
BUSPIRONE HCL 5 MG TABLET
buspirone hydrochloride
$0.0220
per EA
+0.92%
ATENOLOL 25 MG TABLET
atenolol
$0.0217
per EA
+0.14%
DIAZEPAM 2 MG TABLET
diazepam
$0.0212
per EA
-1.80%
METOPROLOL TARTRATE 50 MG TAB
metoprolol tartrate
$0.0195
per EA
+5.12%
METOPROLOL TARTRATE 25 MG TAB
metoprolol tartrate
$0.0159
per EA
-0.63%

FDA Recalls (15)

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

D-0601-2021 →
Terminated
Class III

Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA; Manufactured by: Mylan Institutional, Galway, Ireland. NDC: 67457-196-02

Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.

Initiated: 5/3/2021
D-1576-2020 →
Terminated
Class I

Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 mL Single-Dose Vials per carton (NDC 67457-197-10), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103.

Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.

Initiated: 8/17/2020
D-1575-2020 →
Terminated
Class I

Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Single-Dose Vials per carton (NDC 67457-153-09), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103.

Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.

Initiated: 8/17/2020
D-1484-2020 →
Terminated
Class I

Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50

Presence of Particulate Matter

Initiated: 7/7/2020
D-1271-2020 →
Terminated
Class II

Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA. NDC: 67457-187-50

Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.

Initiated: 5/5/2020
D-1329-2015 →
Terminated
Class I

Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0152-02), Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017.

Presence of Particulate Matter

Initiated: 4/23/2015
D-1334-2015 →
Terminated
Class I

Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1.

Presence of Particulate Matter

Initiated: 3/23/2015
D-1333-2015 →
Terminated
Class I

Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-463-02, UPC 3 67457 46302 5.

Presence of Particulate Matter

Initiated: 3/23/2015
D-1332-2015 →
Terminated
Class I

Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-464-20, UPC 3 67457 46420 6; and b) Distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY 10017, Made in India, NDC 0069-3857-10, UPC 3 00693 85710 4.

Presence of Particulate Matter

Initiated: 3/23/2015
D-1331-2015 →
Terminated
Class I

CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-493-46, UPC 3 67457 49346 6.

Presence of Particulate Matter

Initiated: 3/18/2015
D-1328-2015 →
Terminated
Class I

Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-0146-01; and b) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-467-99.

Presence of Particulate Matter

Initiated: 3/18/2015
D-0422-2015 →
Terminated
Class II

Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103

Lack of Assurance of Sterility; due to leaking vials

Initiated: 2/18/2015
D-0421-2015 →
Terminated
Class II

Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103

Lack of Assurance of Sterility; due to leaking vials

Initiated: 2/18/2015
D-0412-2015 →
Terminated
Class III

DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 100 mL Multi-Dose Vial, Rx Only, Manufactured By: Onco Therapies Limited, Bangalore, 560105, INDIA, Distributed By: Amneal-Agila, LLC, Glasgow, KY, 42141, NDC 53150-317-01.

Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL

Initiated: 2/11/2015
D-0413-2015 →
Terminated
Class III

Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10

Subpotent Drug and Failed Impurities/Degradation Specifications

Initiated: 1/23/2015