Why it was recalled
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Product description
PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b) 10 x 2mL Single Use Vials per box (NDC 72516-024-10); Manufactured for Oryza Pharmaceuticals, Inc.
Lot numbers, UPCs & expiration codes
Lot #: a) 20VPHI037, 20VPHI038, 20VPHI039, Exp 12/31/2022; 21VPHI021, 21VPHI022, 21VPHI023, Exp 6/30/2023; 21VPHI047, 21VPHI048, Exp 10/31/2023; b) 21VPHI023, Exp 6/30/2023
Where it was sold
Nationwide in the U.S.A
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-0742-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 14, 2022
- FDA report date
- Apr 13, 2022
- Quantity
- a) 2,098 boxes; b) 700 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vitae Enim Vitae Scientific, Inc.
Original FDA data
Every field from FDA enforcement report D-0742-2022, exactly as published.
Show all FDA fields
- City
- San Diego
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 89803
- Address
- 3030 Bunker Hill St Ste 203
- Code information
- Lot #: a) 20VPHI037, 20VPHI038, 20VPHI039, Exp 12/31/2022; 21VPHI021, 21VPHI022, 21VPHI023, Exp 6/30/2023; 21VPHI047, 21VPHI048, Exp 10/31/2023; b) 21VPHI023, Exp 6/30/2023
- Postal code
- 92109-5754
- Report date
- Apr 13, 2022
- Product type
- Drugs
- Recall number
- D-0742-2022
- Classification
- Class II
- Recalling firm
- Vitae Enim Vitae Scientific, Inc.
- Product quantity
- a) 2,098 boxes; b) 700 boxes
- Termination date
- Aug 15, 2024
- Reason for recall
- Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b) 10 x 2mL Single Use Vials per box (NDC 72516-024-10); Manufactured for Oryza Pharmaceuticals, Inc.
- Distribution pattern
- Nationwide in the U.S.A
- Recall initiation date
- Mar 14, 2022
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Apr 5, 2022