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
PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL Vials per box (NDC 42494-415-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.
Lot numbers, UPCs & expiration codes
Lot #: a) 20VPSI007, Exp 3/31/2022; 20VPSI015, Exp 5/30/2022; 20VPSI018, Exp 6/1/2022; 20VPSI032, Exp 11/30/2022; 21VPSI002, 21VPSI003, Exp 1/31/2023; 21VPSI006, Exp 3/31/2023; 21VPSI012, 21VPSI020, Exp 5/31/2023; 21VPSI035, Exp 7/31/2023; 21VPSI037, 21VPSI038, Exp 8/31/2023; 21VPSI043, 21VPSI044, Exp 10/31/2023; 21VPSI050, 21VPSI051, Exp 11/30/2023; 22VPSI004, Exp 7/31/2024; 22VPSI006, Exp 8/31/2024; b) 20VPSI008, Exp 3/31/2022; 20VPSI019, Exp 6/30/2022; 21VPSI050, Exp 11/30/2023,
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-0743-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 14, 2022
- FDA report date
- Apr 13, 2022
- Quantity
- a) 21,501 boxes; b) 4,846 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vitae Enim Vitae Scientific, Inc.
Original FDA data
Every field from FDA enforcement report D-0743-2022, 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) 20VPSI007, Exp 3/31/2022; 20VPSI015, Exp 5/30/2022; 20VPSI018, Exp 6/1/2022; 20VPSI032, Exp 11/30/2022; 21VPSI002, 21VPSI003, Exp 1/31/2023; 21VPSI006, Exp 3/31/2023; 21VPSI012, 21VPSI020, Exp 5/31/2023; 21VPSI035, Exp 7/31/2023; 21VPSI037, 21VPSI038, Exp 8/31/2023; 21VPSI043, 21VPSI044, Exp 10/31/2023; 21VPSI050, 21VPSI051, Exp 11/30/2023; 22VPSI004, Exp 7/31/2024; 22VPSI006, Exp 8/31/2024; b) 20VPSI008, Exp 3/31/2022; 20VPSI019, Exp 6/30/2022; 21VPSI050, Exp 11/30/2023,
- Postal code
- 92109-5754
- Report date
- Apr 13, 2022
- Product type
- Drugs
- Recall number
- D-0743-2022
- Classification
- Class II
- Recalling firm
- Vitae Enim Vitae Scientific, Inc.
- Product quantity
- a) 21,501 boxes; b) 4,846 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
- PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL Vials per box (NDC 42494-415-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.
- 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