FDA recall D-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

Reason for recall

Failed Impurities/Degradation Specification: Out of specification for organic impurities

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-01-16

Report date

2024-02-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0339-2024