Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Product description
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57
Lot numbers, UPCs & expiration codes
Lot #22121970, 22122158, 22121971, 22122189, 22122190, 22122277, 22122278, Exp June 2024; 22122521, 22122522, 22122523, Exp July 2024; 22123328, 22123329, 22123330, Exp September 2024.
Where it was sold
The recall product was distributed 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-1145-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 18, 2023
- FDA report date
- Sep 13, 2023
- Quantity
- 99,516 sachets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascend Laboratories, LLC
Original FDA data
Every field from FDA enforcement report D-1145-2023, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 92706
- Address
- 339 Jefferson Rd Ste 101
- Code information
- Lot #22121970, 22122158, 22121971, 22122189, 22122190, 22122277, 22122278, Exp June 2024; 22122521, 22122522, 22122523, Exp July 2024; 22123328, 22123329, 22123330, Exp September 2024.
- Postal code
- 07054-3707
- Report date
- Sep 13, 2023
- Product type
- Drugs
- Recall number
- D-1145-2023
- Classification
- Class III
- Recalling firm
- Ascend Laboratories, LLC
- Product quantity
- 99,516 sachets
- Termination date
- Feb 19, 2026
- Reason for recall
- Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57
- Distribution pattern
- The recall product was distributed nationwide.
- Recall initiation date
- Jul 18, 2023
- Initial firm notification
- Letter
- Center classification date
- Sep 6, 2023