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 $25.19 per unit, with a week-over-week move of -0.9% 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

$25.1927

$0.02 – $3185.94

Avg 7d Change

-0.95%

Across 123 drugs with changes

7d Activity

408326 flat

of 149 total drugs

Portfolio Price Trend

Monthly average NADAC price across all drugs

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 $25.1927 per unit, ranging from $0.0170 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, 40 Mylan Institutional LLC products rose and 83 fell, with a portfolio-wide average change of -0.9%.

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
$45.3441
per ML
+2.32%
FONDAPARINUX 7.5 MG/0.6 ML SYR
fondaparinux sodium
$42.9123
per ML
-1.06%
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
$21.8463
per EA
DAPTOMYCIN 500 MG VIAL
daptomycin
$21.8463
per EA
MEDROXYPROGESTERONE 150 MG/ML
Medroxyprogesterone Acetate
$21.2450
per ML
+4.07%
FONDAPARINUX 2.5 MG/0.5 ML SYR
fondaparinux sodium
$20.8396
per ML
+5.98%
MEDROXYPROGESTERONE 150 MG/ML
Medroxyprogesterone Acetate
$18.7597
per ML
-2.82%
NALOXONE 4 MG/10 ML VIAL
naloxone hydrochloride
$15.7839
per ML
HALOPERIDOL DEC 100 MG/ML VIAL
Haloperidol Decanoate
$13.1831
per ML
-0.52%
NALOXONE 4 MG/10 ML VIAL
naloxone hydrochloride
$11.2094
per ML
FLUPHENAZINE DEC 125 MG/5 ML
FLUPHENAZINE DECANOATE
$9.7074
per ML
+2.32%
HALOPERIDOL DEC 50 MG/ML VIAL
Haloperidol Decanoate
$6.8710
per ML
-2.56%
TRIAMCINOLONE ACET 200 MG/5 ML
TRIAMCINOLONE ACETONIDE
$6.4795
per ML
+0.48%
B-COMPLEX 100 INJECTION
thiamine hydrochloride, riboflavin 5 phosphate sodium, dexpanthenol and niacinamide
$6.1199
per ML
TRIAMCINOLONE ACET 400 MG/10 ML
TRIAMCINOLONE ACETONIDE
$5.2298
per ML
-1.92%
TRIAMCINOLONE ACET 40 MG/ML VL
TRIAMCINOLONE ACETONIDE
$4.7499
per ML
-3.10%
ZOLEDRONIC ACID 4 MG/5 ML VIAL
Zoledronic acid
$4.6828
per ML
CLOZAPINE ODT 100 MG TABLET
clozapine
$4.5621
per EA
-4.95%
NALOXONE 0.4 MG/ML VIAL
naloxone hydrochloride
$4.4135
per ML
+0.83%
NALOXONE 0.4 MG/ML VIAL
naloxone hydrochloride
$4.4135
per ML
+0.83%
ISONIAZID 300 MG TABLET
Isoniazid
$3.4133
per EA
+1.65%
VANCOMYCIN 1 GM VIAL
Vancomycin Hydrochloride
$2.9591
per EA
IMATINIB MESYLATE 400 MG TAB
imatinib
$2.9484
per EA
-2.28%
THIAMINE 200 MG/2 ML VIAL
thiamine hydrochloride
$2.3916
per ML
-0.12%
VANCOMYCIN 500 MG VIAL
Vancomycin Hydrochloride
$2.3054
per EA
HEPARIN SODIUM 10,000 UNIT/ML VIAL
Heparin Sodium
$2.2868
per ML
VORICONAZOLE 200 MG TABLET
voriconazole
$2.2263
per EA
-0.14%
DILTIAZEM 12HR ER 120 MG CAP
diltiazem hydrochloride
$2.1564
per EA
-3.23%
DILTIAZEM 12HR ER 90 MG CAP
diltiazem hydrochloride
$1.8325
per EA
+7.63%
RIMSO-50 SOLUTION
Dimethyl Sulfoxide
$1.7675
per ML
DILTIAZEM 12HR ER 60 MG CAP
diltiazem hydrochloride
$1.4579
per EA
+2.14%
VERAPAMIL ER 120 MG CAPSULE
verapamil hydrochloride
$1.2971
per EA
+0.09%
TRIFLUOPERAZINE 10 MG TABLET
trifluoperazine hydrochloride
$1.2729
per EA
-3.22%
HEPARIN SODIUM 5,000 UNIT/ML VIAL
Heparin Sodium
$1.1958
per ML
+2.97%
POLYETHYLENE GLYCOL 3350 POWD
polyethylene glycol (3350)
$1.1272
per EA
-2.87%
CLOZAPINE 200 MG TABLET
clozapine
$0.9628
per EA
-7.22%
TRIFLUOPERAZINE 5 MG TABLET
trifluoperazine hydrochloride
$0.8947
per EA
+3.43%
THIORIDAZINE 100 MG TABLET
thioridazine hydrochloride
$0.7927
per EA
+2.07%
DIPHENHYDRAMINE 500 MG/10 ML VL
diphenhydramine hydrochloride
$0.7900
per ML
HALOPERIDOL LAC 5 MG/ML VIAL
HALOPERIDOL LACTATE
$0.7852
per ML
+0.83%
THIORIDAZINE 50 MG TABLET
thioridazine hydrochloride
$0.7575
per EA
+1.82%
DEXAMETHASONE 4 MG/ML VIAL
Dexamethasone Sodium Phosphate
$0.6742
per ML
-2.76%
DEXAMETHASONE 4 MG/ML VIAL
Dexamethasone Sodium Phosphate
$0.6742
per ML
-2.76%
IMATINIB MESYLATE 100 MG TAB
imatinib
$0.6632
per EA
-10.46%
TRIFLUOPERAZINE 2 MG TABLET
trifluoperazine hydrochloride
$0.6538
per EA
-2.23%
TOBRAMYCIN 80 MG/2 ML VIAL
Tobramycin
$0.6528
per ML
+1.82%
TACROLIMUS 5 MG CAPSULE (IMMEDIATE RELEASE)
Tacrolimus
$0.6505
per EA
-3.57%
CLOZAPINE 100 MG TABLET
clozapine
$0.6134
per EA
-3.11%
ABACAVIR 300 MG TABLET
abacavir sulfate
$0.6012
per EA
-6.19%
THIORIDAZINE 25 MG TABLET
thioridazine hydrochloride
$0.5763
per EA
-0.40%
SPIRONOLACTONE-HYDROCHLOROTHIAZIDE 25-25 TAB
spironolactone and hydrochlorothiazide
$0.5414
per EA
+1.26%
DEXAMETHASONE 100 MG/10 ML VL
Dexamethasone Sodium Phosphate
$0.5228
per ML
-4.52%
DEXAMETHASONE 100 MG/10 ML VL
Dexamethasone Sodium Phosphate
$0.5228
per ML
-4.52%
CYANOCOBALAMIN 30,000 MCG/30 ML
cyanocobalamine
$0.4930
per ML
ZOLEDRONIC ACID 5 MG/100 ML
Zoledronic Acid
$0.4874
per ML
+3.38%
VORICONAZOLE 50 MG TABLET
voriconazole
$0.4800
per EA
+23.28%
TRIFLUOPERAZINE 1 MG TABLET
trifluoperazine hydrochloride
$0.4310
per EA
+2.94%
ROCURONIUM 50 MG/5 ML VIAL
rocuronium bromide
$0.3942
per ML
THIORIDAZINE 10 MG TABLET
thioridazine hydrochloride
$0.3738
per EA
-5.27%
TRANEXAMIC ACID 1,000 MG/10 ML
tranexamic acid
$0.3603
per ML
-0.94%
METOLAZONE 5 MG TABLET
metolazone
$0.2945
per EA
+1.20%
MYCOPHENOLATE 500 MG TABLET
mycophenolate mofetil
$0.2725
per EA
CLOZAPINE 25 MG TABLET
clozapine
$0.2479
per EA
-3.15%
DOXEPIN 100 MG CAPSULE
doxepin hydrochloride
$0.2459
per EA
-7.03%
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
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
VALACYCLOVIR HCL 500 MG TABLET
valacyclovir hydrochloride
$0.2259
per EA
-1.34%
METOLAZONE 2.5 MG TABLET
metolazone
$0.2234
per EA
+1.72%
DIVALPROEX SOD ER 500 MG TAB
divalproex sodium
$0.1838
per EA
-1.75%
SUCRALFATE 1 GM TABLET
Sucralfate
$0.1830
per EA
-3.83%
SPIRONOLACTONE 100 MG TABLET
spironolactone
$0.1759
per EA
-1.40%
CARBIDOPA-LEVO ER 50-200 TAB
carbidopa and levodopa
$0.1756
per EA
-6.02%
HALOPERIDOL 5 MG TABLET
haloperidol
$0.1752
per EA
-2.73%
HALOPERIDOL 10 MG TABLET
haloperidol
$0.1641
per EA
METHOTREXATE 2.5 MG TABLET
methotrexate
$0.1635
per EA
-0.36%
CHLORDIAZEPOXIDE 25 MG CAPSULE
Chlordiazepoxide Hydrochloride
$0.1603
per EA
+0.04%
TACROLIMUS 1 MG CAPSULE (IMMEDIATE RELEASE)
Tacrolimus
$0.1561
per EA
-3.25%
HALOPERIDOL 2 MG TABLET
haloperidol
$0.1515
per EA
-4.27%
DOXEPIN 50 MG CAPSULE
doxepin hydrochloride
$0.1463
per EA
-3.41%
CHLORDIAZEPOXIDE 10 MG CAPSULE
Chlordiazepoxide Hydrochloride
$0.1421
per EA
+0.06%
PRAZOSIN 5 MG CAPSULE
prazosin hydrochloride
$0.1399
per EA
-3.93%
DIVALPROEX SOD ER 250 MG TAB
divalproex sodium
$0.1383
per EA
+0.01%
TACROLIMUS 0.5 MG CAPSULE (IMMEDIATE RELEASE)
Tacrolimus
$0.1327
per EA
-9.42%
DOXEPIN 25 MG CAPSULE
doxepin hydrochloride
$0.1280
per EA
-2.25%
FENOFIBRATE 145 MG TABLET
fenofibrate
$0.1198
per EA
-0.02%
CARBIDOPA-LEVO ER 25-100 TAB
carbidopa and levodopa
$0.1185
per EA
+2.48%
HALOPERIDOL 1 MG TABLET
haloperidol
$0.1177
per EA
-1.42%
BUSPIRONE HCL 30 MG TABLET
buspirone hydrochloride
$0.1149
per EA
+2.85%
HALOPERIDOL 0.5 MG TABLET
haloperidol
$0.1130
per EA
-5.86%
MIDODRINE HCL 5 MG TABLET
midodrine hydrochloride
$0.1112
per EA
-0.53%
MIRTAZAPINE 45 MG TABLET
Mirtazapine
$0.1078
per EA
-1.40%
LANSOPRAZOLE DR 30 MG CAPSULE
lansoprazole
$0.1067
per EA
-0.74%
MIRTAZAPINE 30 MG TABLET
Mirtazapine
$0.0887
per EA
-2.30%
CHLORTHALIDONE 25 MG TABLET
chlorthalidone
$0.0882
per EA
-0.71%
SPIRONOLACTONE 50 MG TABLET
spironolactone
$0.0875
per EA
-2.03%
PRAZOSIN 1 MG CAPSULE
prazosin hydrochloride
$0.0853
per EA
+0.71%
PRAVASTATIN SODIUM 40 MG TAB
Pravastatin Sodium
$0.0846
per EA
+0.01%
FENOFIBRATE 48 MG TABLET
fenofibrate
$0.0839
per EA
-1.96%
PRAZOSIN 2 MG CAPSULE
prazosin hydrochloride
$0.0823
per EA
-3.28%
METOPROLOL SUCC ER 100 MG TAB
metoprolol succinate
$0.0822
per EA
LEVOTHYROXINE 175 MCG TABLET
levothyroxine sodium
$0.0800
per EA
+0.13%
DOXEPIN 10 MG CAPSULE
doxepin hydrochloride
$0.0790
per EA
-2.60%
LEVETIRACETAM 500 MG TABLET
levetiracetam
$0.0763
per EA
-2.22%
ATORVASTATIN 80 MG TABLET
atorvastatin calcium
$0.0700
per EA
-0.85%
MIRTAZAPINE 15 MG TABLET
Mirtazapine
$0.0658
per EA
-1.20%
CETIRIZINE HCL 10 MG TABLET
cetirizine hydrochloride
$0.0640
per EA
-0.03%
LEVOTHYROXINE 150 MCG TABLET
levothyroxine sodium
$0.0635
per EA
-3.01%
LEVOTHYROXINE 137 MCG TABLET
levothyroxine sodium
$0.0630
per EA
-2.04%
PRAVASTATIN SODIUM 20 MG TAB
Pravastatin Sodium
$0.0622
per EA
+1.67%
LEVOTHYROXINE 112 MCG TABLET
levothyroxine sodium
$0.0616
per EA
-2.82%
LEVOTHYROXINE 125 MCG TABLET
levothyroxine sodium
$0.0584
per EA
-3.60%
ALLOPURINOL 300 MG TABLET
allopurinol
$0.0567
per EA
+0.71%
LOPERAMIDE 2 MG CAPSULE
loperamide hydrochloride
$0.0541
per EA
+3.86%
LORATADINE 10 MG TABLET
loratadine
$0.0525
per EA
-0.85%
LEVOTHYROXINE 88 MCG TABLET
levothyroxine sodium
$0.0522
per EA
-2.50%
LEVOTHYROXINE 100 MCG TABLET
levothyroxine sodium
$0.0509
per EA
-2.17%
LEVOTHYROXINE 75 MCG TABLET
levothyroxine sodium
$0.0488
per EA
-0.20%
HYDRALAZINE 50 MG TABLET
Hydralazine Hydrochloride
$0.0456
per EA
+0.29%
LEVOTHYROXINE 50 MCG TABLET
levothyroxine sodium
$0.0448
per EA
-3.03%
METOCLOPRAMIDE 10 MG TABLET
Metoclopramide
$0.0446
per EA
+0.63%
SPIRONOLACTONE 25 MG TABLET
spironolactone
$0.0443
per EA
-1.05%
BUSPIRONE HCL 15 MG TABLET
buspirone hydrochloride
$0.0423
per EA
-1.49%
ATORVASTATIN 40 MG TABLET
atorvastatin calcium
$0.0379
per EA
-0.97%
METOCLOPRAMIDE 5 MG TABLET
Metoclopramide
$0.0371
per EA
-1.36%
ATENOLOL 100 MG TABLET
atenolol
$0.0365
per EA
+0.33%
LEVOTHYROXINE 25 MCG TABLET
levothyroxine sodium
$0.0362
per EA
-2.92%
PANTOPRAZOLE SOD DR 40 MG TAB
pantoprazole sodium
$0.0361
per EA
-0.08%
HYDRALAZINE 25 MG TABLET
Hydralazine Hydrochloride
$0.0352
per EA
-0.98%
ALLOPURINOL 100 MG TABLET
allopurinol
$0.0334
per EA
+0.03%
BUSPIRONE HCL 10 MG TABLET
buspirone hydrochloride
$0.0292
per EA
-1.52%
DIAZEPAM 5 MG TABLET
diazepam
$0.0291
per EA
-0.85%
DIAZEPAM 10 MG TABLET
diazepam
$0.0290
per EA
+1.33%
ATORVASTATIN 20 MG TABLET
atorvastatin calcium
$0.0285
per EA
-1.76%
HYDRALAZINE 10 MG TABLET
Hydralazine Hydrochloride
$0.0270
per EA
-1.28%
ATENOLOL 50 MG TABLET
atenolol
$0.0247
per EA
-2.80%
ATORVASTATIN 10 MG TABLET
atorvastatin calcium
$0.0245
per EA
-1.80%
DIAZEPAM 2 MG TABLET
diazepam
$0.0221
per EA
+1.05%
BUSPIRONE HCL 5 MG TABLET
buspirone hydrochloride
$0.0219
per EA
-0.77%
ATENOLOL 25 MG TABLET
atenolol
$0.0214
per EA
-2.77%
METOPROLOL TARTRATE 50 MG TAB
metoprolol tartrate
$0.0189
per EA
-0.94%
METOPROLOL TARTRATE 25 MG TAB
metoprolol tartrate
$0.0170
per EA
-0.70%

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