Drug product
Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
D-1232-2019
Product summary
- Event
- Event 82620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 215 bags
- Official record key
drug-enforcement:D-1232-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: ED041912 Exp. 4/13/2019; ED051912 Exp. 4/14/2019; ED081912 Exp. 4/17/2019; ED091911 Exp. 4/18/2019; ED101912 Exp. 4/19/2019; ED111910 Exp. 4/20/2019
Distribution pattern: NC
Derived failure modes
-
Sterility assurance
Lack of sterility