Status
Terminated
Drug Enforcement D-0866-2023
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
Report Date
June 14, 2023
Termination Date
April 11, 2024
Product Information
- 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
- Product quantity
- 2,736 boxes
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed to 10 distributors who may have further distribute the product to the retail level.
Location & Firm
- Recalling firm
- Viatris Inc
- Address
-
1000 Mylan Blvd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0866-2023
- Event ID
- 92366
- Recall initiation date
- May 25, 2023
- Center classification date
- June 5, 2023
- Code info
- Lot #: 101241A, Exp 10/23
- More code info
- —