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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0743-2022 |
| Event ID | 89803 |
| Distribution | Nationwide in the U.S.A |
| Quantity | a) 21,501 boxes; b) 4,846 boxes |
| Recall Reason | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. |
| Drug Classification | Class II |
| Drug Code Info | 20220413 |
| Recall Initiation Date | 20220314 |
| Report Date | 20220413 |
| Classification Date | 20220405 |
| Address | 3030 Bunker Hill St Ste 203 San Diego, CA 92109-5754 United States |
| Recalling Firm | Vitae Enim Vitae Scientific, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Similar To |