Why it was recalled
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Product description
Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-20
Lot numbers, UPCs & expiration codes
Lot #: SM8719040-A, Exp. Date 02/2021
Where it was sold
Nationwide within the United States
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-0852-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 7, 2020
- FDA report date
- Feb 19, 2020
- Quantity
- 30432 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0852-2020, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84910
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: SM8719040-A, Exp. Date 02/2021
- Postal code
- 08520-1401
- Report date
- Feb 19, 2020
- Product type
- Drugs
- Recall number
- D-0852-2020
- Classification
- Class II
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 30432 bottles
- Termination date
- Nov 17, 2022
- Reason for recall
- Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-20
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Feb 7, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 19, 2020