Drug product
Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466
D-0603-2017
Product summary
- Event
- Event 76661
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3879 syringes
- Official record key
drug-enforcement:D-0603-2017
Official wording
Reason: Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%
Code information: Lot Numbers: 170110030M, 170110029M and 170070058M
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling; Label Mixup