Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Product description
Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC 67457-445-60
Lot numbers, UPCs & expiration codes
Lot #: 7008990, exp. date Dec-2022; 7009025, exp. date Feb-2023; 7009085, 7009086, exp. date Apr-2023
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-0774-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 7, 2022
- FDA report date
- Apr 27, 2022
- Quantity
- 33,893 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0774-2022, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 89910
- Address
- 3711 Collins Ferry Rd
- Code information
- Lot #: 7008990, exp. date Dec-2022; 7009025, exp. date Feb-2023; 7009085, 7009086, exp. date Apr-2023
- Postal code
- 26505-2362
- Report date
- Apr 27, 2022
- Product type
- Drugs
- Recall number
- D-0774-2022
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc
- Product quantity
- 33,893 vials
- Termination date
- May 23, 2023
- Reason for recall
- Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC 67457-445-60
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 7, 2022
- Initial firm notification
- Letter
- Center classification date
- Apr 15, 2022