Reported Sep 13, 2023 · Terminated
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem…
Ascend Laboratories, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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, 3 g 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
Lot #22121970221221582212197122122189221221902212227722122278Exp June 2024221225212212252222122523Exp July 2024221233282212332922123330Exp September 2024
- Amount recalled
- 99,516 sachets
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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