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 $25.23 per unit, with a week-over-week move of +0.5% 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

$25.2297

$0.02 – $3185.94

Avg 7d Change

+0.48%

Across 124 drugs with changes

7d Activity

517325 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 $25.2297 per unit, ranging from $0.0160 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, 51 Mylan Institutional LLC products rose and 73 fell, with a portfolio-wide average change of +0.5%.

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
$46.0327
per ML
-0.54%
FONDAPARINUX 7.5 MG/0.6 ML SYR
fondaparinux sodium
$42.7121
per ML
+0.08%
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
MEDROXYPROGESTERONE 150 MG/ML
Medroxyprogesterone Acetate
$22.8495
per ML
+24.10%
DAPTOMYCIN 500 MG VIAL
daptomycin
$22.6865
per EA
+8.89%
DAPTOMYCIN 500 MG VIAL
daptomycin
$22.6865
per EA
+8.89%
FONDAPARINUX 2.5 MG/0.5 ML SYR
fondaparinux sodium
$22.1623
per ML
+3.24%
MEDROXYPROGESTERONE 150 MG/ML
Medroxyprogesterone Acetate
$18.3134
per ML
-0.78%
NALOXONE 4 MG/10 ML VIAL
naloxone hydrochloride
$15.7839
per ML
HALOPERIDOL DEC 100 MG/ML VIAL
Haloperidol Decanoate
$14.3235
per ML
+10.36%
NALOXONE 4 MG/10 ML VIAL
naloxone hydrochloride
$11.2094
per ML
FLUPHENAZINE DEC 125 MG/5 ML
FLUPHENAZINE DECANOATE
$10.8919
per ML
+6.46%
HALOPERIDOL DEC 50 MG/ML VIAL
Haloperidol Decanoate
$6.7398
per ML
-2.51%
TRIAMCINOLONE ACET 200 MG/5 ML
TRIAMCINOLONE ACETONIDE
$6.3280
per ML
-1.57%
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
$4.8690
per ML
-1.97%
TRIAMCINOLONE ACET 40 MG/ML VL
TRIAMCINOLONE ACETONIDE
$4.8380
per ML
+1.02%
ZOLEDRONIC ACID 4 MG/5 ML VIAL
Zoledronic acid
$4.6828
per ML
CLOZAPINE ODT 100 MG TABLET
clozapine
$4.2514
per EA
-3.92%
NALOXONE 0.4 MG/ML VIAL
naloxone hydrochloride
$4.0147
per ML
-5.05%
NALOXONE 0.4 MG/ML VIAL
naloxone hydrochloride
$4.0147
per ML
-5.05%
ISONIAZID 300 MG TABLET
Isoniazid
$3.4917
per EA
-0.59%
VANCOMYCIN 1 GM VIAL
Vancomycin Hydrochloride
$2.9591
per EA
IMATINIB MESYLATE 400 MG TAB
imatinib
$2.8764
per EA
-0.94%
VERAPAMIL ER 120 MG CAPSULE
verapamil hydrochloride
$2.3305
per EA
+37.76%
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
$2.1624
per ML
-3.34%
DILTIAZEM 12HR ER 120 MG CAP
diltiazem hydrochloride
$1.9794
per EA
-4.27%
VORICONAZOLE 200 MG TABLET
voriconazole
$1.8017
per EA
-4.32%
DILTIAZEM 12HR ER 90 MG CAP
diltiazem hydrochloride
$1.7991
per EA
-1.44%
RIMSO-50 SOLUTION
Dimethyl Sulfoxide
$1.7675
per ML
DILTIAZEM 12HR ER 60 MG CAP
diltiazem hydrochloride
$1.5119
per EA
-2.53%
TRIFLUOPERAZINE 10 MG TABLET
trifluoperazine hydrochloride
$1.2372
per EA
+0.91%
HEPARIN SODIUM 5,000 UNIT/ML VIAL
Heparin Sodium
$1.2024
per ML
POLYETHYLENE GLYCOL 3350 POWD
polyethylene glycol (3350)
$1.1547
per EA
+3.93%
TRIFLUOPERAZINE 5 MG TABLET
trifluoperazine hydrochloride
$0.9301
per EA
+1.35%
CLOZAPINE 200 MG TABLET
clozapine
$0.9160
per EA
-5.21%
THIORIDAZINE 100 MG TABLET
thioridazine hydrochloride
$0.8024
per EA
+0.89%
DIPHENHYDRAMINE 500 MG/10 ML VL
diphenhydramine hydrochloride
$0.7900
per ML
HALOPERIDOL LAC 5 MG/ML VIAL
HALOPERIDOL LACTATE
$0.7890
per ML
-0.02%
THIORIDAZINE 50 MG TABLET
thioridazine hydrochloride
$0.7492
per EA
-2.54%
TOBRAMYCIN 80 MG/2 ML VIAL
Tobramycin
$0.7395
per ML
+13.76%
VORICONAZOLE 50 MG TABLET
voriconazole
$0.7046
per EA
+26.53%
DEXAMETHASONE 4 MG/ML VIAL
Dexamethasone Sodium Phosphate
$0.6719
per ML
+2.19%
DEXAMETHASONE 4 MG/ML VIAL
Dexamethasone Sodium Phosphate
$0.6719
per ML
+2.19%
TACROLIMUS 5 MG CAPSULE (IMMEDIATE RELEASE)
Tacrolimus
$0.6591
per EA
-0.84%
IMATINIB MESYLATE 100 MG TAB
imatinib
$0.6114
per EA
-1.01%
CLOZAPINE 100 MG TABLET
clozapine
$0.6076
per EA
-1.45%
TRIFLUOPERAZINE 2 MG TABLET
trifluoperazine hydrochloride
$0.5976
per EA
-3.77%
THIORIDAZINE 25 MG TABLET
thioridazine hydrochloride
$0.5718
per EA
-0.48%
ABACAVIR 300 MG TABLET
abacavir sulfate
$0.5380
per EA
-3.37%
DEXAMETHASONE 100 MG/10 ML VL
Dexamethasone Sodium Phosphate
$0.5042
per ML
+0.41%
DEXAMETHASONE 100 MG/10 ML VL
Dexamethasone Sodium Phosphate
$0.5042
per ML
+0.41%
SPIRONOLACTONE-HYDROCHLOROTHIAZIDE 25-25 TAB
spironolactone and hydrochlorothiazide
$0.4960
per EA
-3.68%
CYANOCOBALAMIN 30,000 MCG/30 ML
cyanocobalamine
$0.4930
per ML
ZOLEDRONIC ACID 5 MG/100 ML
Zoledronic Acid
$0.4774
per ML
-3.05%
TRIFLUOPERAZINE 1 MG TABLET
trifluoperazine hydrochloride
$0.4358
per EA
+0.63%
ROCURONIUM 50 MG/5 ML VIAL
rocuronium bromide
$0.3942
per ML
TRANEXAMIC ACID 1,000 MG/10 ML
tranexamic acid
$0.3868
per ML
+2.14%
THIORIDAZINE 10 MG TABLET
thioridazine hydrochloride
$0.3820
per EA
+0.35%
MYCOPHENOLATE 500 MG TABLET
mycophenolate mofetil
$0.2725
per EA
DOXEPIN 100 MG CAPSULE
doxepin hydrochloride
$0.2669
per EA
+1.23%
METOLAZONE 5 MG TABLET
metolazone
$0.2643
per EA
-1.67%
CLOZAPINE 25 MG TABLET
clozapine
$0.2553
per EA
+2.68%
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
$0.2279
per EA
+3.12%
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
$0.2240
per EA
+0.57%
DIVALPROEX SOD ER 500 MG TAB
divalproex sodium
$0.1836
per EA
+4.37%
HALOPERIDOL 5 MG TABLET
haloperidol
$0.1782
per EA
-0.77%
CARBIDOPA-LEVO ER 50-200 TAB
carbidopa and levodopa
$0.1735
per EA
+3.54%
SUCRALFATE 1 GM TABLET
Sucralfate
$0.1725
per EA
-3.50%
SPIRONOLACTONE 100 MG TABLET
spironolactone
$0.1699
per EA
-2.65%
HALOPERIDOL 10 MG TABLET
haloperidol
$0.1641
per EA
CHLORDIAZEPOXIDE 25 MG CAPSULE
Chlordiazepoxide Hydrochloride
$0.1599
per EA
-0.40%
HALOPERIDOL 2 MG TABLET
haloperidol
$0.1579
per EA
+8.52%
METHOTREXATE 2.5 MG TABLET
methotrexate
$0.1566
per EA
-1.12%
DOXEPIN 50 MG CAPSULE
doxepin hydrochloride
$0.1535
per EA
+3.77%
TACROLIMUS 1 MG CAPSULE (IMMEDIATE RELEASE)
Tacrolimus
$0.1518
per EA
+0.36%
CHLORDIAZEPOXIDE 10 MG CAPSULE
Chlordiazepoxide Hydrochloride
$0.1432
per EA
+0.64%
DOXEPIN 25 MG CAPSULE
doxepin hydrochloride
$0.1368
per EA
+7.42%
PRAZOSIN 5 MG CAPSULE
prazosin hydrochloride
$0.1293
per EA
-1.61%
DIVALPROEX SOD ER 250 MG TAB
divalproex sodium
$0.1287
per EA
-4.91%
TACROLIMUS 0.5 MG CAPSULE (IMMEDIATE RELEASE)
Tacrolimus
$0.1256
per EA
-3.08%
FENOFIBRATE 145 MG TABLET
fenofibrate
$0.1214
per EA
+1.37%
HALOPERIDOL 1 MG TABLET
haloperidol
$0.1187
per EA
+12.61%
BUSPIRONE HCL 30 MG TABLET
buspirone hydrochloride
$0.1187
per EA
+2.40%
CARBIDOPA-LEVO ER 25-100 TAB
carbidopa and levodopa
$0.1137
per EA
-1.21%
MIDODRINE HCL 5 MG TABLET
midodrine hydrochloride
$0.1134
per EA
+1.30%
LANSOPRAZOLE DR 30 MG CAPSULE
lansoprazole
$0.1071
per EA
-1.73%
MIRTAZAPINE 45 MG TABLET
Mirtazapine
$0.1052
per EA
+0.26%
HALOPERIDOL 0.5 MG TABLET
haloperidol
$0.0939
per EA
-14.36%
MIRTAZAPINE 30 MG TABLET
Mirtazapine
$0.0869
per EA
-0.26%
PRAZOSIN 1 MG CAPSULE
prazosin hydrochloride
$0.0858
per EA
-0.21%
PRAZOSIN 2 MG CAPSULE
prazosin hydrochloride
$0.0850
per EA
+0.13%
PRAVASTATIN SODIUM 40 MG TAB
Pravastatin Sodium
$0.0848
per EA
+0.52%
SPIRONOLACTONE 50 MG TABLET
spironolactone
$0.0846
per EA
-1.56%
CHLORTHALIDONE 25 MG TABLET
chlorthalidone
$0.0840
per EA
-0.96%
METOPROLOL SUCC ER 100 MG TAB
metoprolol succinate
$0.0822
per EA
FENOFIBRATE 48 MG TABLET
fenofibrate
$0.0814
per EA
-1.07%
DOXEPIN 10 MG CAPSULE
doxepin hydrochloride
$0.0776
per EA
-0.13%
LEVOTHYROXINE 175 MCG TABLET
levothyroxine sodium
$0.0765
per EA
-4.90%
LEVETIRACETAM 500 MG TABLET
levetiracetam
$0.0739
per EA
-1.53%
ATORVASTATIN 80 MG TABLET
atorvastatin calcium
$0.0692
per EA
+0.09%
MIRTAZAPINE 15 MG TABLET
Mirtazapine
$0.0645
per EA
-1.12%
CETIRIZINE HCL 10 MG TABLET
cetirizine hydrochloride
$0.0629
per EA
-3.69%
LEVOTHYROXINE 137 MCG TABLET
levothyroxine sodium
$0.0627
per EA
+0.61%
PRAVASTATIN SODIUM 20 MG TAB
Pravastatin Sodium
$0.0620
per EA
-0.88%
LEVOTHYROXINE 150 MCG TABLET
levothyroxine sodium
$0.0597
per EA
-4.53%
LEVOTHYROXINE 112 MCG TABLET
levothyroxine sodium
$0.0589
per EA
-2.34%
LEVOTHYROXINE 125 MCG TABLET
levothyroxine sodium
$0.0570
per EA
+0.19%
LOPERAMIDE 2 MG CAPSULE
loperamide hydrochloride
$0.0565
per EA
+5.63%
ALLOPURINOL 300 MG TABLET
allopurinol
$0.0546
per EA
-2.22%
LORATADINE 10 MG TABLET
loratadine
$0.0532
per EA
+1.61%
LEVOTHYROXINE 100 MCG TABLET
levothyroxine sodium
$0.0507
per EA
-1.71%
LEVOTHYROXINE 88 MCG TABLET
levothyroxine sodium
$0.0502
per EA
-4.42%
LEVOTHYROXINE 75 MCG TABLET
levothyroxine sodium
$0.0463
per EA
-2.73%
HYDRALAZINE 50 MG TABLET
Hydralazine Hydrochloride
$0.0455
per EA
-0.04%
METOCLOPRAMIDE 10 MG TABLET
Metoclopramide
$0.0438
per EA
-2.17%
SPIRONOLACTONE 25 MG TABLET
spironolactone
$0.0430
per EA
-0.67%
BUSPIRONE HCL 15 MG TABLET
buspirone hydrochloride
$0.0423
per EA
+0.05%
LEVOTHYROXINE 50 MCG TABLET
levothyroxine sodium
$0.0406
per EA
-6.04%
ATORVASTATIN 40 MG TABLET
atorvastatin calcium
$0.0370
per EA
-0.94%
ATENOLOL 100 MG TABLET
atenolol
$0.0370
per EA
+2.07%
LEVOTHYROXINE 25 MCG TABLET
levothyroxine sodium
$0.0357
per EA
-0.53%
HYDRALAZINE 25 MG TABLET
Hydralazine Hydrochloride
$0.0356
per EA
+0.62%
METOCLOPRAMIDE 5 MG TABLET
Metoclopramide
$0.0354
per EA
-2.24%
PANTOPRAZOLE SOD DR 40 MG TAB
pantoprazole sodium
$0.0352
per EA
-2.09%
ALLOPURINOL 100 MG TABLET
allopurinol
$0.0317
per EA
-3.59%
DIAZEPAM 10 MG TABLET
diazepam
$0.0290
per EA
-0.31%
DIAZEPAM 5 MG TABLET
diazepam
$0.0287
per EA
-1.44%
BUSPIRONE HCL 10 MG TABLET
buspirone hydrochloride
$0.0279
per EA
-2.31%
ATORVASTATIN 20 MG TABLET
atorvastatin calcium
$0.0276
per EA
-1.18%
HYDRALAZINE 10 MG TABLET
Hydralazine Hydrochloride
$0.0271
per EA
+0.63%
ATENOLOL 50 MG TABLET
atenolol
$0.0238
per EA
-1.08%
ATORVASTATIN 10 MG TABLET
atorvastatin calcium
$0.0232
per EA
-3.25%
BUSPIRONE HCL 5 MG TABLET
buspirone hydrochloride
$0.0217
per EA
+0.51%
ATENOLOL 25 MG TABLET
atenolol
$0.0217
per EA
+2.80%
DIAZEPAM 2 MG TABLET
diazepam
$0.0216
per EA
-0.05%
METOPROLOL TARTRATE 50 MG TAB
metoprolol tartrate
$0.0185
per EA
-0.16%
METOPROLOL TARTRATE 25 MG TAB
metoprolol tartrate
$0.0160
per EA
-2.56%

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