Drug product
lidocaine HCl, 1%, 10 mg per 1 mL, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3102.
D-0060-2017
Product summary
- Event
- Event 73925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2961 syringes
- Official record key
drug-enforcement:D-0060-2017
Official wording
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Code information: Lot Numbers: 15118064M, 15119066M, 15119075M, 15124006M, 15133061M, 15133066M, 15134057M, 15140063M, 15149053M, 151720021M, 151880315M, Exp between 07/15/15-10/12/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
loss of potency