Why it was recalled
Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
Product description
Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for: Akorn, Inc., Lake Forest, IL --- NDC 17478-151-42
Lot numbers, UPCs & expiration codes
Lot: 12RIF4A, Expiration Date: 9/30/2014
Where it was sold
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-1571-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 5, 2014
- FDA report date
- Oct 1, 2014
- Quantity
- 5,539 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-1571-2014, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69013
- Address
- 1925 W. Field Court, Suite 300
- Code information
- Lot: 12RIF4A, Expiration Date: 9/30/2014
- Postal code
- 60045
- Report date
- Oct 1, 2014
- Product type
- Drugs
- Recall number
- D-1571-2014
- Classification
- Class III
- Recalling firm
- Akorn, Inc.
- Product quantity
- 5,539 vials
- Termination date
- May 21, 2015
- Reason for recall
- Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for: Akorn, Inc., Lake Forest, IL --- NDC 17478-151-42
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 5, 2014
- Initial firm notification
- Letter
- Center classification date
- Sep 22, 2014