FDAFDA · Food and drugs·Recall number 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) Somerset New Jersey 00873-4120, NDC #0037-9001-05
Published June 14, 2023 · Recall initiated: May 25, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Viatris Inc
- Distributor
- Product was distributed to 10 distributors who may have further distribute the product to the retail level.
- Lot
- Lot #: 101241A, Exp 10/23
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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