FDA recall D-0866-2023

Viatris Inc · Class II · 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

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2023-05-25
Report date
2023-06-14
Termination date
2024-04-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Canonsburg, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0866-2023