FDA Drug recall D-0743-2022
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…
- FDA Drug
- Class II
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of 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… by Vitae Enim Vitae Scientific, citing lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0743-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-14 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Vitae Enim Vitae Scientific |
| Distribution | US |
Product
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.
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.
Identifiers
| ndc | 42494-416-25 |
|---|---|
| ndc | 42494-416-03 |
| ndc | 42494-415-25 |
| ndc | 42494-415-03 |
| code_info | Lot #: a) 20VPSI007, Exp 3/31/2022; 20VPSI015, Exp 5/30/2022; 20VPSI018, Exp 6/1/2022; 20VPSI032, Exp 11/30/2022; 21VPS…Lot #: a) 20VPSI007, Exp 3/31/2022; 20VPSI015, Exp 5/30/2022; 20VPSI018, Exp 6/1/2022; 20VPSI032, Exp 11/30/2022; 21VPSI002, 21VPSI003, Exp 1/31/2023; 21VPSI006, Exp 3/31/2023; 21VPSI012, 21VPSI020, Exp 5/31/2023; 21VPSI035, Exp 7/31/2023; 21VPSI037, 21VPSI038, Exp 8/31/2023; 21VPSI043, 21VPSI044, Exp 10/31/2023; 21VPSI050, 21VPSI051, Exp 11/30/2023; 22VPSI004, Exp 7/31/2024; 22VPSI006, Exp 8/31/2024; b) 20VPSI008, Exp 3/31/2022; 20VPSI019, Exp 6/30/2022; 21VPSI050, Exp 11/30/2023, |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0743-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.