D-0180-2024 Class II Terminated

Recalled by CARDINAL HEALTHCARE — Dublin, OH

FDA drug recall D-0180-2024 was initiated by CARDINAL HEALTHCARE on January 26, 2022 and is designated Class II. Reason for recall: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. The recall status is terminated (terminated September 29, 2024). Affected quantity: 1 unit.

Recall Details

Product Type
Drugs
Report Date
January 3, 2024
Initiation Date
January 26, 2022
Termination Date
September 29, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02

Reason for Recall

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

Distribution Pattern

Nationwide USA

Code Information

Batch 100023687