FDA Drug recall D-1230-2019
Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, 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 Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, 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-1230-2019 |
| 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
Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Reason
Lack of sterility assurance.
Identifiers
| code_info | Lots: ED041911 Exp. 4/13/2019; ED051910 Exp. 4/14/2019; ED081910 Exp. 4/17/2019; ED091909 Exp. 4/18/2019; ED101910 Exp. 4/19/2019; ED111908 Exp. 4/20/2019 |
|---|
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-1230-2019%22
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