FDA-Drug2017-02-01Class II

Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73

Teva Pharmaceuticals USA
Hazard

Subpotency: due to a low, out of specification test result for assay during stability testing.

Sold states
United States and Puerto Rico
Affected count
133,601 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 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0440-2017

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