Drug product
Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
D-1223-2019
Product summary
- Event
- Event 82620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1135 syringes
- Official record key
drug-enforcement:D-1223-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: ED041902 Exp. 4/13/2019; ED051903 Exp. 04/14/2019; ED081902 Exp. 4/17/2019; ED091902 Exp. 4/18/2019; ED101903 Exp. 4/19/2019; ED111902 Exp. 4/20/2019
Distribution pattern: NC
Derived failure modes
-
Sterility assurance
Lack of sterility