FDA-Drug2022-04-13Class II
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.
Vitae Enim Vitae Scientific, Inc.
Hazard
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Sold states
Nationwide in the U.S.A
Affected count
a) 18,531 boxes; b) 4,492 boxes
Manufactured in
3030 Bunker Hill St Ste 203, San Diego, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0744-2022Don't want to check this manually?
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