FDA Drug recall D-1209-2019
Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg
- FDA Drug
- Class II
- terminated
- Published 2019-05-01
On 2019-05-01 the FDA classified a Class II recall of Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg by Cmc Enterprise Pharmacy, citing lack of sterility assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1209-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-12 |
| Published | 2019-05-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cmc Enterprise Pharmacy |
| Distribution | NC |
Product
Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Reason
Lack of sterility assurance.
Identifiers
| code_info | Lots: EA141908 Exp. 4/14/2019; EA171909 Exp. 4/17/2019; EA211906 Exp. 4/21/2019; EA251908 Exp. 4/25/2019; EB041905 Exp.…Lots: EA141908 Exp. 4/14/2019; EA171909 Exp. 4/17/2019; EA211906 Exp. 4/21/2019; EA251908 Exp. 4/25/2019; EB041905 Exp. 5/6/2019; EB071907 Exp. 5/8/2019; EB151909 Exp. 5/16/2019; EC041906 Exp. 6/2/2019; EC111907 Exp. 6/9/2019; EC181908 Exp. 6/16/2019; EC201907 Exp. 6/18/2019 |
|---|
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-1209-2019%22
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