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FDARecalled Jun 14, 2023 · #D-0866-2023

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) S...

Hazard

Class II — temporary health risk

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

Product details

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
Type
Drugs
Manufacturer
Viatris Inc
Model numbers
101241A
UPCs