Skip to content
Recall Observatory FDA recall evidence

Drug product

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

D-0866-2023

May 25, 2023

Class II

Product summary

Firm
Viatris Inc
Event
Event 92366
Status
Terminated
Classification
Class II
Quantity
2,736 boxes
Official record key
drug-enforcement:D-0866-2023

Official wording

Reason: 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.

Code information: Lot #: 101241A, Exp 10/23

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

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations