Viatris Inc recalls Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampul
Recalled June 14, 2023 · FDA recall D-0866-2023 · Viatris
Hazard
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. · FDA Class II
Units
2,736 boxes
Sold at
Product was distributed to 10 distributors who may have further distribute the product to the retail level.
Description
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
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
Manufacturer(s)
Viatris Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →