Why it was recalled
Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
Product description
RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
Lot numbers, UPCs & expiration codes
Lot #: 14RIF1(A), Expiry: 9/30/2016.
Where it was sold
US: Nationwide
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-0231-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 20, 2015
- FDA report date
- Nov 25, 2015
- Quantity
- 6861 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0231-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 72192
- Address
- 1925 W. Field Court, Suite 300
- Code information
- Lot #: 14RIF1(A), Expiry: 9/30/2016.
- Postal code
- 60045
- Report date
- Nov 25, 2015
- Product type
- Drugs
- Recall number
- D-0231-2016
- Classification
- Class III
- Recalling firm
- Akorn, Inc.
- Product quantity
- 6861 Vials
- Termination date
- Jan 26, 2017
- Reason for recall
- Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
- Distribution pattern
- US: Nationwide
- Recall initiation date
- Aug 20, 2015
- Initial firm notification
- Letter
- Center classification date
- Nov 13, 2015