Class II · Moderate risk Ongoing
Amoxicillin and Clavulanate Potassium for Oral Suspension USP
Reason Subpotent drug; Clavulanate Potassium component
Amoxicillin for Oral Suspension
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.
What was recalled
Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960.
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- NDC code
- 0093-4160-78
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-803-2013
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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