Why it was recalled
Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
Product description
Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.
Lot numbers, UPCs & expiration codes
Lot: 7008334, Exp April 2020; 7008417, Exp Oct 2020
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0139-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 7, 2019
- FDA report date
- Oct 16, 2019
- Quantity
- 19,165 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Laboratories Limited (Sterile Products Division)
Original FDA data
Every field from FDA enforcement report D-0139-2020, exactly as published.
Show all FDA fields
- City
- Bangalore
- Status
- Terminated
- Country
- India
- Event ID
- 83914
- Address
- Opp. Iim-B, Bilekahalli , Bannerghatta Road
- Code information
- Lot: 7008334, Exp April 2020; 7008417, Exp Oct 2020
- Report date
- Oct 16, 2019
- Product type
- Drugs
- Recall number
- D-0139-2020
- Classification
- Class II
- Recalling firm
- Mylan Laboratories Limited (Sterile Products Division)
- Product quantity
- 19,165 vials
- Termination date
- Mar 9, 2023
- Reason for recall
- Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 7, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 10, 2019