Recalls / Class II
Class IID-0866-2023
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
- Affected lot / code info
- Lot #: 101241A, Exp 10/23
Why it was recalled
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.
Recalling firm
- Firm
- Viatris Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1000 Mylan Blvd, Canonsburg, Pennsylvania 15317-5853
Distribution
- Quantity
- 2,736 boxes
- Distribution pattern
- Product was distributed to 10 distributors who may have further distribute the product to the retail level.
Timeline
- Recall initiated
- 2023-05-25
- FDA classified
- 2023-06-05
- Posted by FDA
- 2023-06-14
- Terminated
- 2024-04-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0866-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.