Drug product
Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
D-1212-2019
Product summary
- Event
- Event 82620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6667 syringes
- Official record key
drug-enforcement:D-1212-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: EA241908 Exp. 4/24/2019; EB011905 Exp. 5/2/2019; EB081909 Exp. 5/9/2019; EB151910 Exp. 5/16/2019; EB251909 Exp. 5/26/2019; EC061907 Exp. 6/4/2019; EC151906 Exp. 6/13/2019
Distribution pattern: NC
Derived failure modes
-
Sterility assurance
Lack of sterility