Drug product
Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
D-1221-2019
Product summary
- Event
- Event 82620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 705 syringes
- Official record key
drug-enforcement:D-1221-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: ED041901 Exp. 4/13/2019; ED051901 Exp. 4/14/2019; ED081901 Exp. 4/17/2019; ED01901 Exp. 4/18/2019; ED101901 Exp. 4/19/2019; ED111901 Exp. 4/20/2019
Distribution pattern: NC
Derived failure modes
-
Sterility assurance
Lack of sterility