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
Reported: June 14, 2023 Initiated: May 25, 2023 #D-0866-2023
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.
Details
- Recalling Firm
- Viatris Inc
- Units Affected
- 2,736 boxes
- Distribution
- Product was distributed to 10 distributors who may have further distribute the product to the retail level.
- Location
- Canonsburg, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Viatris Inc. Units affected: 2,736 boxes.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 14, 2023. Severity: Moderate. Recall number: D-0866-2023.
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