Why it was recalled
Subpotent Drug
Product description
Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-2272-34
Lot numbers, UPCs & expiration codes
Lot #: 100047634 Exp. Date 4/2025; 35449379A, Exp. Date 7/2024
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-0561-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 4, 2024
- FDA report date
- Jun 26, 2024
- Quantity
- 34,448 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc
Original FDA data
Every field from FDA enforcement report D-0561-2024, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94750
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot #: 100047634 Exp. Date 4/2025; 35449379A, Exp. Date 7/2024
- Postal code
- 07054-1120
- Report date
- Jun 26, 2024
- Product type
- Drugs
- Recall number
- D-0561-2024
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Product quantity
- 34,448 bottles
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-2272-34
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jun 4, 2024
- Center classification date
- Jun 18, 2024