D-0868-2017 Class III Terminated
FDA drug recall D-0868-2017 was initiated by Sandoz Inc on April 26, 2017 and is designated Class III. Reason for recall: Subpotent Drug; Clavulanic Acid The recall status is terminated (terminated August 19, 2019). Affected quantity: 4,464 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 7, 2017
- Initiation Date
- April 26, 2017
- Termination Date
- August 19, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,464 bottles
Product Description
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
Reason for Recall
Subpotent Drug; Clavulanic Acid
Distribution Pattern
NY, OH
Code Information
Lot FP8735, 8/2017