Class II · Moderate risk Ongoing
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only…
Reason Subpotent drug; Clavulanate Potassium component
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotency: due to a low, out of specification test result for assay during stability testing.
What was recalled
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
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 0093-4150-73
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0440-2017
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, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canada By…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Amoxicillin Capsules, USP, 500 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0781-2613-01
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC…
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, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED…
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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