Drug recall
Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box…
FDA recall event 92366 · Class II · Viatris Inc
Key facts
| Event ID | 92366 |
|---|---|
| Recall numbers | D-0866-2023 |
| Recalling firm | Viatris Inc |
| Product type | Drugs |
| Products | 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)… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| 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… |
| Initiation date | May 25, 2023 |
| Report date | Jun 14, 2023 |
| Termination date | Apr 11, 2024 |
| City | Canonsburg |
| State | PA |
| Country | United States |
| FEI number | 3011055092 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: