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Recall D-0743-2022

Description: PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL Vials per box (NDC 42494-415-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.

Recall D-0743-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0743-2022
Event ID89803
DistributionNationwide in the U.S.A
Quantitya) 21,501 boxes; b) 4,846 boxes
Recall ReasonLack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Drug ClassificationClass II
Drug Code Info20220413
Recall Initiation Date20220314
Report Date20220413
Classification Date20220405
Address3030 Bunker Hill St Ste 203
San Diego, CA 92109-5754
United States
Recalling FirmVitae Enim Vitae Scientific, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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