Recall archive / FDA drug enforcement
Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 am... — FDA record D-0866-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 25, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- 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
- Recalling firm
- Viatris Inc
- Quantity
- 2,736 boxes
- Agency-reported status
- Terminated
- Source record identifier
- D-0866-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot #: 101241A, Exp 10/23 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product was distributed to 10 distributors who may have further distribute the product to the retail level.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jun 14, 2023
- Recall initiation date
- May 25, 2023
- Center classification date
- Jun 5, 2023
- Termination date
- Apr 11, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.