FDA-Drug2019-04-24Class II

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.

Teva Pharmaceuticals USA
Hazard

Subpotent Product: assay results for Amoxicillin were below the specification limits.

Sold states
Nationwide in the USA and Puerto Rico
Affected count
171,488 150 mL and 80 mL bottles
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1205-2019

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