PHENOBARBITAL Sodium Injection recall: Sterility Concern
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.
Why was PHENOBARBITAL Sodium Injection 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- 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.
- Recalling firm
- Vitae Enim Vitae Scientific, Inc.
- Quantity
- a) 18,531 boxes; b) 4,492 boxes
- Distribution
- Nationwide in the U.S.A
- Recall date
- April 13, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)