Why it was recalled
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Product description
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
Lot numbers, UPCs & expiration codes
Lot#: 3192818, Exp 10/31/2022; 3199700, Exp 03/31/2023; 3203853, Exp 02/29/2024
Where it was sold
USA Nationwide and Puerto Rico
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-1547-2022
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 21, 2022
- FDA report date
- Oct 5, 2022
- Quantity
- 18,145 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-1547-2022, exactly as published.
Show all FDA fields
- City
- Gurnee
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 90880
- Address
- 5605 Centerpoint Ct Ste A
- Code information
- Lot#: 3192818, Exp 10/31/2022; 3199700, Exp 03/31/2023; 3203853, Exp 02/29/2024
- Postal code
- 60031-5278
- Report date
- Oct 5, 2022
- Product type
- Drugs
- Recall number
- D-1547-2022
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 18,145 bottles
- Reason for recall
- Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
- Distribution pattern
- USA Nationwide and Puerto Rico
- Recall initiation date
- Sep 21, 2022
- Initial firm notification
- Letter
- Center classification date
- Sep 28, 2022