FDA-Drug2023-06-14Class II
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
Viatris Inc
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.
Sold states
Product was distributed to 10 distributors who may have further distribute the product to the retail level.
Affected count
2,736 boxes
Manufactured in
1000 Mylan Blvd, Canonsburg, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0866-2023Don't want to check this manually?
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