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, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x 1mL Vials per box (NDC 42494-416-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.
Lot numbers, UPCs & expiration codes
Lot # a) 20VPSI011, Exp. 4/30/2022; 20VPSI014, Exp. 5/31/2022; 20VPSI020, 20VPSI022, 20VPSI023, Exp. 7/31/2022; 21VPSI007, Exp. 3/31/2023; 21VPSI013, Exp. 5/31/2023; 21VPSI027, Exp. 6/30/2023; 21VPSI039, Exp. 8/31/2023; 21VPSI042, Exp. 10/31/2023; 21VPSI049, Exp. 11/30/2023; 21VPSI052, Exp. 12/31/2023; 22VPSI005, Exp. 7/31/2024; 22VPSI007, Exp. 8/31/2024; Lots: b) 22VPSI007, Exp. 8/31/2024; 20VPSI009, Exp. 3/31/2022; 20VPSI020, Exp. 7/31/2022; 21VPSI039, Exp. 8/31/2023; 22VPSI005, Exp. 7/31/2024.
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-0744-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 14, 2022
- FDA report date
- Apr 13, 2022
- Quantity
- a) 18,531 boxes; b) 4,492 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vitae Enim Vitae Scientific, Inc.
Original FDA data
Every field from FDA enforcement report D-0744-2022, 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) 20VPSI011, Exp. 4/30/2022; 20VPSI014, Exp. 5/31/2022; 20VPSI020, 20VPSI022, 20VPSI023, Exp. 7/31/2022; 21VPSI007, Exp. 3/31/2023; 21VPSI013, Exp. 5/31/2023; 21VPSI027, Exp. 6/30/2023; 21VPSI039, Exp. 8/31/2023; 21VPSI042, Exp. 10/31/2023; 21VPSI049, Exp. 11/30/2023; 21VPSI052, Exp. 12/31/2023; 22VPSI005, Exp. 7/31/2024; 22VPSI007, Exp. 8/31/2024; Lots: b) 22VPSI007, Exp. 8/31/2024; 20VPSI009, Exp. 3/31/2022; 20VPSI020, Exp. 7/31/2022; 21VPSI039, Exp. 8/31/2023; 22VPSI005, Exp. 7/31/2024.
- Postal code
- 92109-5754
- Report date
- Apr 13, 2022
- Product type
- Drugs
- Recall number
- D-0744-2022
- Classification
- Class II
- Recalling firm
- Vitae Enim Vitae Scientific, Inc.
- Product quantity
- a) 18,531 boxes; b) 4,492 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, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x 1mL Vials per box (NDC 42494-416-03), 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