Drug 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.
D-1230-2019
Product summary
- Event
- Event 82620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1310 syringes
- Official record key
drug-enforcement:D-1230-2019
Official wording
Reason: Lack of sterility assurance.
Code information: 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
Distribution pattern: NC
Derived failure modes
-
Sterility assurance
Lack of sterility