FDA Drug recall D-0629-2016
CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in 600ML Homepumps, Rx Only
- FDA Drug
- Class II
- terminated
- Published 2016-02-03
On 2016-02-03 the FDA classified a Class II recall of CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in 600ML Homepumps, Rx Only by Sentara Enterprises, citing lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0629-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-18 |
| Published | 2016-02-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sentara Enterprises |
| Distribution | NC, VA |
Product
CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Identifiers
| code_info | All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15, b) 30-Sep-15, 1-Oct-15, c) 28-Sep-15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0629-2016%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.