Why it was recalled
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Product description
Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), 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
lOTS #: 22121458, 22121459, 22121460, 22121461, 22121462, 22121463, 22121464, Exp 4/2024; 22121176, 22121407, 22121465, Exp 3/2024; 22121761, 22121762, 22121763, 22121764, 22121766, 22121968, 22121969, Exp 5/2024.
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-0339-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 16, 2024
- FDA report date
- Feb 28, 2024
- Quantity
- 71,244 sachets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascend Laboratories, LLC
Original FDA data
Every field from FDA enforcement report D-0339-2024, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 93816
- Address
- 339 Jefferson Rd Ste 101
- Code information
- lOTS #: 22121458, 22121459, 22121460, 22121461, 22121462, 22121463, 22121464, Exp 4/2024; 22121176, 22121407, 22121465, Exp 3/2024; 22121761, 22121762, 22121763, 22121764, 22121766, 22121968, 22121969, Exp 5/2024.
- Postal code
- 07054-3707
- Report date
- Feb 28, 2024
- Product type
- Drugs
- Recall number
- D-0339-2024
- Classification
- Class II
- Recalling firm
- Ascend Laboratories, LLC
- Product quantity
- 71,244 sachets
- Reason for recall
- Failed Impurities/Degradation Specification: Out of specification for organic impurities
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), 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
- Nationwide in the USA
- Recall initiation date
- Jan 16, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 20, 2024