Recalls / Class II
Class IID-0339-2024
Product
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
- Brand name
- Fosfomycin Tromethamine
- Generic name
- Fosfomycin Tromethamine
- Active ingredient
- Fosfomycin Tromethamine
- Route
- Oral
- NDC
- 67877-749
- FDA application
- ANDA214554
- Affected lot / code info
- 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.
Why it was recalled
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Recalling firm
- Firm
- Ascend Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, N/A, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- 71,244 sachets
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-01-16
- FDA classified
- 2024-02-20
- Posted by FDA
- 2024-02-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0339-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.