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Medicine / D-0014-2027

U.S. Food and Drug AdministrationD-0014-2027

Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd.,…

Class II Distributed nationwide or U.S.-wide Status: Ongoing

What was recalled

Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-579-67.

Recalling firm

Cipla USA, Inc.

Reason for recall

Failed Impurities/Degradation Specifications

Where it went

USA Nationwide.

Shown as U.S. Food and Drug Administration published it (shortened where marked …). Recall Shelf does not change recall facts and is not affiliated with the agency.