Teva Pharmaceuticals USA recalls Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle
Recalled April 24, 2019 · FDA recall D-1205-2019 · Teva Pharmaceuticals USA
Hazard
Subpotent Product: assay results for Amoxicillin were below the specification limits. · FDA Class II
Units
171,488 150 mL and 80 mL bottles
Sold at
Nationwide in the USA and Puerto Rico
Description
Subpotent Product: assay results for Amoxicillin were below the specification limits.
Product
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454.
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →