Drug product
lidocaine HCl, 1%, 30 mg per 3 mL, 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3104.
D-0061-2017
Product summary
- Event
- Event 73925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 syringes
- Official record key
drug-enforcement:D-0061-2017
Official wording
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Code information: Lot Numbers: 15117146M, 15121045M, 15125052M, 15131008M, 15133051M, 15140028M, 15149043M, 151890293M, Exp between 07/15/15-10/12/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
loss of potency