FDA recall D-0201-2024

CARDINAL HEALTHCARE · Class II · drug

Product

Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01

Reason for recall

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

Distribution

Nationwide USA

Key facts

Status
Terminated
Initiation date
2022-01-26
Report date
2024-01-03
Termination date
2024-09-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0201-2024