Class II · Moderate risk Ongoing
Amoxicillin and Clavulanate Potassium for Oral Suspension USP
Reason Subpotent drug; Clavulanate Potassium component
Amoxicillin for Oral Suspension USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Superpotent drug: Out of specification test result for assay during stability testing.
What was recalled
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
- Recalling firm
- Teva North America
- NDC code
- 0093-4161-76
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1470-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Amoxicillin recalls
See all
Class II · Moderate risk Ongoing
Amoxicillin and Clavulanate Potassium Tablets USP
Reason Subpotent Drug
Class II · Moderate risk Terminated
Amoxicillin Capsules
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
AMOXICILLIN Tablets
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
AMOXICILLIN for Oral Suspension USP
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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