Why it was recalled
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Product description
AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20
Lot numbers, UPCs & expiration codes
Batch LJ9004
Where it was sold
Nationwide USA
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-0166-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 26, 2022
- FDA report date
- Jan 3, 2024
- Quantity
- 2 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CARDINAL HEALTHCARE
Original FDA data
Every field from FDA enforcement report D-0166-2024, exactly as published.
Show all FDA fields
- City
- Dublin
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 89450
- Address
- 7200 Cardinal Pl W
- Code information
- Batch LJ9004
- Postal code
- 43017-1094
- Report date
- Jan 3, 2024
- Product type
- Drugs
- Recall number
- D-0166-2024
- Classification
- Class II
- Recalling firm
- CARDINAL HEALTHCARE
- Product quantity
- 2 units
- Termination date
- Sep 29, 2024
- Reason for recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Jan 26, 2022
- Initial firm notification
- Letter
- Center classification date
- Dec 26, 2023