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Sedative Injection Recalled
A lack of sterility assurance has caused Vitae Enim Vitae Scientific Inc to recall numerous lots of phenobarbital sodium injection manufactured for Cameron Pharmaceuticals. According to the April 13, 2022, US Food and Drug Administration (FDA) Enforcement Report, deviations from Current Good Manufacturing Practices called into question the sterility of products intended to be sterile.
The recall affects the following products, which were distributed throughout the United States:
- phenobarbital sodium injection, 65 mg/mL, packaged as 3 x 1-mL vials per box (NDC 42494-415-03), from lots 20VPSI008 (Exp. 3/31/22); 20VPSI019 (Exp. 6/30/22); and 21VPSI050 (Exp. 11/30/23);
- phenobarbital sodium injection, 65 mg/mL, packaged as 25 x 1-mL vials per box (NDC 42494-415-25), from lots 20VPSI007 (Exp. 3/31/22); 20VPSI015 (Exp. 5/30/22); 20VPSI018 (Exp. 6/1/22); 20VPSI032 (Exp. 11/30/22); 21VPSI002 and 21VPSI003 (Exp. 1/31/23); 21VPSI006 (Exp. 3/31/23); 21VPSI012 and 21VPSI020 (Exp. 5/31/23); 21VPSI035 (Exp. 7/31/23); 21VPSI037 and 21VPSI038 (Exp. 8/31/23); 21VPSI043 and 21VPSI044 (Exp. 10/31/23); 21VPSI050 and 21VPSI051 (Exp. 11/30/23); 22VPSI004 (Exp. 7/31/24); and 22VPSI006 (Exp. 8/31/24);
- phenobarbital sodium injection, 130 mg/mL, packaged as 3 x 1-mL vials per box (NDC 42494-416-03), from lots 22VPSI007 (Exp. 8/31/24); 20VPSI009 (Exp. 3/31/22); 20VPSI020 (Exp. 7/31/22); 21VPSI039 (Exp. 8/31/23); and 22VPSI005 (Exp. 7/31/24); and
- phenobarbital sodium injection, 130 mg/mL, packaged as 25 x 1-mL vials per box (NDC 42494-416-25), from lots 20VPSI011 (Exp. 4/30/22); 20VPSI014 (Exp. 5/31/22); 20VPSI020, 20VPSI022, and 20VPSI023 (Exp. 7/31/22); 21VPSI007 (Exp. 3/31/23); 21VPSI013 (Exp. 5/31/23); 21VPSI027 (Exp. 6/30/23); 21VPSI039 (Exp. 8/31/23); 21VPSI042 (Exp. 10/31/23); 21VPSI049 (Exp. 11/30/23); 21VPSI052 (Exp. 12/31/23); 22VPSI005 (Exp. 7/31/24); and 22VPSI007 (Exp. 8/31/24).
Vitae Enim Vitae Scientific voluntarily initiated the recall March 14, 2022. On April 5, 2022, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Phenobarbital sodium injection is a Schedule IV controlled substance and sedative.
