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.
Check against the official notice below — it lists the full affected range.
Vitae Enim Vitae Scientific, Inc. is recalling Phenobarbital Sodium Injection, USP, 130 mg/mL in two package sizes: boxes containing 25 vials (NDC 42494-416-25) and boxes containing 3 vials (NDC 42494-416-03). The recall affects 18,531 boxes of the 25-vial packaging and 4,492 boxes of the 3-vial packaging distributed nationwide in the United States. The product is being recalled due to lack of assurance of sterility caused by deviations from Current Good Manufacturing Practices that call into question whether the sterile products remain sterile.
The recall involves multiple lot numbers with expiration dates ranging from March 31, 2022 through August 31, 2024. Affected lot numbers for the 25-vial boxes include 20VPSI011, 20VPSI014, 20VPSI020, 20VPSI022, 20VPSI023, 21VPSI007, 21VPSI013, 21VPSI027, 21VPSI039, 21VPSI042, 21VPSI049, 21VPSI052, 22VPSI005, and 22VPSI007. For the 3-vial boxes, affected lots are 22VPSI007, 20VPSI009, 20VPSI020, 21VPSI039, and 22VPSI005. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
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. Distribution: Nationwide in the U.S.A Quantity: a) 18,531 boxes; b) 4,492 boxes Lot/code info: 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.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.