Reported Feb 28, 2024 · Ongoing
Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only,…
Ascend Laboratories, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ascend Laboratories, LLC · 339 Jefferson Rd Ste 101 · Parsippany, NJ · 07054-3707
Is this the product you have?
- Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only
- Manufactured byAlkem Laboratories Ltd., INDIA
- Distributed byAscend Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57
- Lot codes and dates
lOTS #: 22121458221214592212146022121461221214622212146322121464Exp 4/2024221211762212140722121465Exp 3/202422121761221217622212176322121764221217662212196822121969Exp 5/2024
- Amount recalled
- 71,244 sachets
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specification: Out of specification for organic impurities
This product could cause temporary or reversible health problems — stop using it.
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