Why it was recalled
Subpotent Drug; Clavulanic Acid
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
Lot numbers, UPCs & expiration codes
Lot FP8735, 8/2017
Where it was sold
NY, OH
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0868-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 26, 2017
- FDA report date
- Jun 7, 2017
- Quantity
- 4,464 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-0868-2017, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77117
- Address
- 100 College Rd W
- Code information
- Lot FP8735, 8/2017
- Postal code
- 08540-6604
- Report date
- Jun 7, 2017
- Product type
- Drugs
- Recall number
- D-0868-2017
- Classification
- Class III
- Recalling firm
- Sandoz Inc
- Product quantity
- 4,464 bottles
- Termination date
- Aug 19, 2019
- Reason for recall
- Subpotent Drug; Clavulanic Acid
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- NY, OH
- Recall initiation date
- Apr 26, 2017
- Initial firm notification
- Letter
- Center classification date
- May 26, 2017