Vitae Enim Vitae Scientific, Inc.: Drug Recall
Recall #D-0744-2022 · 03/14/2022
Class II: Risk
Recall Details
- Recall Number
- D-0744-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Vitae Enim Vitae Scientific, Inc.
- Status
- Terminated
- Date Initiated
- 03/14/2022
- Location
- San Diego, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 18,531 boxes; b) 4,492 boxes
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.
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.
Distribution Pattern
Nationwide in the U.S.A
Other Recalls by Vitae Enim Vitae Scientific, Inc.
- Class II: Risk 03/14/2022
- Class II: Risk 03/14/2022
- Class II: Risk 03/14/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.