Mylan Institutional LLC Recalls

All product recalls associated with Mylan Institutional LLC.

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Recall Summary

Total Recalls

15

Past Year

0

Class I (Serious)

9

Most Recent

May 2021

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–15 of 15 recalls

Thiamine Injection (Mylan) – Labeling Error (2021)

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.

Class IIILow

FDAMay 3, 2021Nationwide• Mylan Institutional LLC

Tranexamic Acid Injection (Mylan) – Labeling Mix-Up (2020)

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.

Class IHigh

FDAAug 17, 2020Nationwide• Mylan Institutional LLC

Amiodarone HCl Injection (Mylan) – Labeling Mix-Up (2020)

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.

Class IHigh

FDAAug 17, 2020Nationwide• Mylan Institutional LLC

Daptomycin for Injection (Mylan) – Particulate Matter (2020)

Presence of Particulate Matter

Class IHigh

FDAJul 7, 2020Nationwide• Mylan Institutional LLC

Aloprim Injection (Mylan Institutional) – Discoloration (2020)

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.

Class IIModerate

FDAMay 5, 2020Nationwide• Mylan Institutional LLC

Cytarabine Injection (Mylan) – particulate matter (2015)

Presence of Particulate Matter

Class IHigh

FDAApr 23, 2015Nationwide• Mylan Institutional LLC

Gemcitabine Injection (Mylan) – particulate contamination (2015)

Presence of Particulate Matter

Class IHigh

FDAMar 23, 2015Nationwide• Mylan Institutional LLC

Gemcitabine Injection (Mylan) – particulate contamination (2015)

Presence of Particulate Matter

Class IHigh

FDAMar 23, 2015Nationwide• Mylan Institutional LLC

Gemcitabine Injection (Mylan) – particulate contamination (2015)

Presence of Particulate Matter

Class IHigh

FDAMar 23, 2015Nationwide• Mylan Institutional LLC

Methotrexate Injection (Mylan) – Particulate Matter (2015)

Presence of Particulate Matter

Class IHigh

FDAMar 18, 2015Nationwide• Mylan Institutional LLC

CARBOplatin Injection (Mylan) – Particulate Matter (2015)

Presence of Particulate Matter

Class IHigh

FDAMar 18, 2015Nationwide• Mylan Institutional LLC

Haloperidol Decanoate 100mg Injection (Mylan) – Sterility Issue (2015)

Lack of Assurance of Sterility; due to leaking vials

Class IIModerate

FDAFeb 18, 2015Nationwide• Mylan Institutional LLC

Haloperidol Decanoate 50mg Injection (Mylan) – Sterility Issue (2015)

Lack of Assurance of Sterility; due to leaking vials

Class IIModerate

FDAFeb 18, 2015Nationwide• Mylan Institutional LLC

Doxorubicin Injection (Mylan) – Product Mispack (2015)

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

Class IIILow

FDAFeb 11, 2015Nationwide• Mylan Institutional LLC

Nicardipine Hydrochloride Injection (Mylan) – Potency Issue (2015)

Subpotent Drug and Failed Impurities/Degradation Specifications

Class IIILow

FDAJan 23, 2015Nationwide• Mylan Institutional LLC

Stay Informed

Mylan Institutional LLC Recalls

Recall Summary

Thiamine Injection (Mylan) – Labeling Error (2021)

Tranexamic Acid Injection (Mylan) – Labeling Mix-Up (2020)

Amiodarone HCl Injection (Mylan) – Labeling Mix-Up (2020)

Daptomycin for Injection (Mylan) – Particulate Matter (2020)

Aloprim Injection (Mylan Institutional) – Discoloration (2020)

Cytarabine Injection (Mylan) – particulate matter (2015)

Gemcitabine Injection (Mylan) – particulate contamination (2015)

Gemcitabine Injection (Mylan) – particulate contamination (2015)

Gemcitabine Injection (Mylan) – particulate contamination (2015)

Methotrexate Injection (Mylan) – Particulate Matter (2015)

CARBOplatin Injection (Mylan) – Particulate Matter (2015)

Haloperidol Decanoate 100mg Injection (Mylan) – Sterility Issue (2015)

Haloperidol Decanoate 50mg Injection (Mylan) – Sterility Issue (2015)

Doxorubicin Injection (Mylan) – Product Mispack (2015)

Nicardipine Hydrochloride Injection (Mylan) – Potency Issue (2015)