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.
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
Lot numbers, UPCs & expiration codes
Lot #: 101241A, Exp 10/23
Where it was sold
Product was distributed to 10 distributors who may have further distribute the product to the retail level.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0866-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 25, 2023
- FDA report date
- Jun 14, 2023
- Quantity
- 2,736 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Viatris Inc
Original FDA data
Every field from FDA enforcement report D-0866-2023, exactly as published.
Show all FDA fields
- City
- Canonsburg
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 92366
- Address
- 1000 Mylan Blvd
- Code information
- Lot #: 101241A, Exp 10/23
- Postal code
- 15317-5853
- Report date
- Jun 14, 2023
- Product type
- Drugs
- Recall number
- D-0866-2023
- Classification
- Class II
- Recalling firm
- Viatris Inc
- Product quantity
- 2,736 boxes
- Termination date
- Apr 11, 2024
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to 10 distributors who may have further distribute the product to the retail level.
- Recall initiation date
- May 25, 2023
- Initial firm notification
- Letter
- Center classification date
- Jun 5, 2023