Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76

FDA recall notice · announced August 31, 2016 · Teva

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76

Reason for recall

Superpotent drug: Out of specification test result for assay during stability testing.

Notes

Distribution: Nationwide
Lot/code information: Lot # 35434158A, Exp 6/17
Quantity: 53,328 bottles
Status: Terminated
Products in this recall event:
- Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76 (D-1470-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.