Phenobarbital Sodium Injection
FDA Recall NDC 42494-415
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Phenobarbital Sodium (NDC 42494-415). A significant event, classified as Class II, was initiated on Mar 14, 2022 by Cameron Pharmaceuticals. The reported reason for this action was: "Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Mar 14, 2022
Apr 13, 2022
a) 18,531 boxes; b) 4,492 boxes
Recall Profile & Regulatory Data
Event ID
89803
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Vitae Enim Vitae Scientific, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.A
Termination Date
Aug 15, 2024
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.
Batch or Lot Expiration 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.
Affected Packages Involved in this Recall
42494-416-25Product
42494-416-03Product
42494-415-25Product
42494-415-03Product
Class II Terminated
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Mar 14, 2022
Apr 13, 2022
a) 21,501 boxes; b) 4,846 boxes
Recall Profile & Regulatory Data
Event ID
89803
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Vitae Enim Vitae Scientific, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.A
Termination Date
Aug 15, 2024
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.
Batch or Lot Expiration 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
Affected Packages Involved in this Recall
42494-416-25Product
42494-416-03Product
42494-415-25Product
42494-415-03Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
