Class II · Moderate risk Ongoing
Amoxicillin and Clavulanate Potassium for Oral Suspension USP
Reason Subpotent drug; Clavulanate Potassium component
Amoxicillin for Oral Suspension
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point.
What was recalled
Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC 43598-222-52); c)150 mL (NDC 43598-222-53) bottles, Rx only, Dist. By: Dr. REDDY'S Laboratories, Inc., Bridgewater, NJ 08807
- Recalling firm
- Dr Reddys Laboratories Tennessee LLC
- NDC code
- 43598-222-80
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-239-2013
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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