FDA Drug recall D-0612-2016
CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in 7.3ML Syringes, c) 380MG in 7.6ML Syringes, d) 400MG in 8ML Sy…
- FDA Drug
- Class II
- terminated
- Published 2016-02-03
On 2016-02-03 the FDA classified a Class II recall of CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in 7.3ML Syringes, c) 380MG in 7.6ML Syringes, d) 400MG in 8ML Sy… 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-0612-2016 |
| 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
CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in 7.3ML Syringes, c) 380MG in 7.6ML Syringes, d) 400MG in 8ML Syringes, e) 460MG in 9.2ML Syringes, f) 475MG in 9.5ML Syringes, g) 500MG in 10ML Syringes, h) 580MG in 116ML Homepumps, i) 600MG in 120ML Homepumps, j) 650MG in 13ML Syringes, k) 800MG in 40ML Homepumps, l) 950MG in 19 mL Syringes, 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) 24-Sep-15, b) 24-Sep-15, 27-Sep-15, c) 26-Sep-15, d)…All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 24-Sep-15, b) 24-Sep-15, 27-Sep-15, c) 26-Sep-15, d) 24-Sep-15, e) 27-Sep-15, f) 26-Sep-15, 27-Sept-15, g) 24-Sep-15, h) 26-Sep-15, i) 27-Sep-15, j) 26-Sep-15, k) 21-Sep-15 l) 24-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-0612-2016%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.