PlainRecalls
FDA Drug Moderate Class II Terminated

AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20

Reported: January 3, 2024 Initiated: January 26, 2022 #D-0166-2024

Product Description

AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20

Reason for Recall

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Details

Recalling Firm
CARDINAL HEALTHCARE
Units Affected
2 units
Distribution
Nationwide USA
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20. Recalled by CARDINAL HEALTHCARE. Units affected: 2 units.
Why was this product recalled?
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 3, 2024. Severity: Moderate. Recall number: D-0166-2024.