Drug product
Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205 877-550-5059
D-0918-2018
Product summary
- Event
- Event 80425
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3984 syringes
- Official record key
drug-enforcement:D-0918-2018
Official wording
Reason: Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
Code information: Lot #: 20180507@21, Exp 7/1/2018; 20180511@9, 20180511@24, Exp 7/5/2018; 20180518@24, 20180518@31, 20180518@32, Exp 7/12/2018; 20180531@21, Exp 7/25/2018; 20180601@11, Exp 7/26/2018
Distribution pattern: United States
Derived failure modes
-
Potency or specification failure
Subpotent