Class II
Ongoing
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
This recall is currently active, issued February 28, 2024. It was issued by Ascend Laboratories, Llc.
- Company
- Ascend Laboratories, Llc
- Recall Initiated
- January 16, 2024
- Posted
- February 28, 2024
- Recall Number
- D-0339-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 71,244 sachets
- Firm Location
- Parsippany, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Distribution
Nationwide in the USA
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.
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