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.
Reported: April 13, 2022 Initiated: March 14, 2022 #D-0744-2022
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.
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.
Details
- Recalling Firm
- Vitae Enim Vitae Scientific, Inc.
- Units Affected
- a) 18,531 boxes; b) 4,492 boxes
- Distribution
- Nationwide in the U.S.A
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Vitae Enim Vitae Scientific, Inc.. Units affected: a) 18,531 boxes; b) 4,492 boxes.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 13, 2022. Severity: Moderate. Recall number: D-0744-2022.
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