FDAFDA · Food and drugs·Recall number D-0743-2022
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.
Published April 13, 2022 · Recall initiated: March 14, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- PHENOBARBITAL SODIUM
- Manufacturer
- Vitae Enim Vitae Scientific, Inc.
- Distributor
- Nationwide in the U.S.A
- Lot
- 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,
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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