Recalls / Class II
Class IID-0743-2022
Product
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.
- Brand name
- Phenobarbital Sodium
- Generic name
- Phenobarbital Sodium
- Active ingredient
- Phenobarbital Sodium
- Route
- Intramuscular
- NDCs
- 42494-415, 42494-416
- Affected lot / code info
- 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,
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.
Recalling firm
- Firm
- Vitae Enim Vitae Scientific, Inc.
- Manufacturer
- Cameron Pharmaceuticals
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 3030 Bunker Hill St Ste 203, San Diego, California 92109-5754
Distribution
- Quantity
- a) 21,501 boxes; b) 4,846 boxes
- Distribution pattern
- Nationwide in the U.S.A
Timeline
- Recall initiated
- 2022-03-14
- FDA classified
- 2022-04-05
- Posted by FDA
- 2022-04-13
- Terminated
- 2024-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0743-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.