D-0866-2023 Class II Terminated
FDA drug recall D-0866-2023 was initiated by Viatris Inc on May 25, 2023 and is designated Class II. 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 represente… The recall status is terminated (terminated April 11, 2024). Affected quantity: 2,736 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- June 14, 2023
- Initiation Date
- May 25, 2023
- Termination Date
- April 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,736 boxes
Product Description
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 Pattern
Product was distributed to 10 distributors who may have further distribute the product to the retail level.
Code Information
Lot #: 101241A, Exp 10/23