Drug product
lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3450.
D-0069-2017
Product summary
- Event
- Event 73925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3159 syringes
- Official record key
drug-enforcement:D-0069-2017
Official wording
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Code information: Lot Numbers: 15117053M, 15117054M, 15124056M, 15128001M, 15128002M, 15131021M, 15133067M, 15141028M, 15147089M, 15147090M, 151740185M, 151740188M, Exp between 07/15/15-10/12/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
loss of potency