Viatris Inc: Drug Recall

Recall #D-0866-2023 · 05/25/2023

Class II: Risk

Recall Details

Recall Number
D-0866-2023
Classification
Class II
Product Type
Drug
Recalling Firm
Viatris Inc
Status
Terminated
Date Initiated
05/25/2023
Location
Canonsburg, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,736 boxes

Reason for Recall

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Product Description

Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05

Distribution Pattern

Product was distributed to 10 distributors who may have further distribute the product to the retail level.

Other Recalls by Viatris Inc

View all recalls by Viatris Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.