D-0425-2021 Class II Terminated

Recalled by Cardinal Health Inc. — Dublin, OH

FDA drug recall D-0425-2021 was initiated by Cardinal Health Inc. on March 15, 2021 and is designated Class II. Reason for recall: CGMP Deviations: Intermittent exposure to temperature excursion during storage. The recall status is terminated (terminated June 17, 2024). Affected quantity: 325 CARTONS.

Recall Details

Product Type
Drugs
Report Date
June 2, 2021
Initiation Date
March 15, 2021
Termination Date
June 17, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
325 CARTONS

Product Description

TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML ; NDC/UPC 60505-0593-4; RX; DROPS

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Distribution Pattern

FL, GA, SC

Code Information

RW4409