Drug product
0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478.
D-0374-2019
Product summary
- Event
- Event 81895
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,711 syringes
- Official record key
drug-enforcement:D-0374-2019
Official wording
Reason: Subpotent
Code information: Service Code 2K2466 and 2K2470 183320004S, 183330008S, 183340002S, 183340003S, 183300004S, 183310007S, 183370041S, 183310043S, 183370042S, 183320003S, 183380007S, 183250013S, 183250014S, 183320005S, 183330009S, 183370007S, 183390044S, 183400006S, 183410003S.
Distribution pattern: Product was distributed throughout the United States.
Derived failure modes
-
Potency or specification failure
Subpotent