Recalls / Class III
Class IIID-0868-2017
Product
Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-20
- Brand name
- Amoxicillin And Clavulanate Potassium
- Generic name
- Amoxicillin And Clavulanate Potassium
- Active ingredients
- Amoxicillin, Clavulanate Potassium
- Route
- Oral
- NDCs
- 0781-1831, 0781-1874, 0781-1852, 0781-6102, 0781-6104
- FDA application
- ANDA065064
- Affected lot / code info
- Lot FP8735, 8/2017
Why it was recalled
Subpotent Drug; Clavulanic Acid
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- 4,464 bottles
- Distribution pattern
- NY, OH
Timeline
- Recall initiated
- 2017-04-26
- FDA classified
- 2017-05-26
- Posted by FDA
- 2017-06-07
- Terminated
- 2019-08-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0868-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.