Drug product
lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 1 mL in a syringe, Rx only, PharMEDium, Product code 2R3345.
D-0063-2017
Product summary
- Event
- Event 73925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5900 syringes
- Official record key
drug-enforcement:D-0063-2017
Official wording
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Code information: Lot numbers: 15118046M, 15128003M, 15128111M, 15133006M, 15139004M, 15140015C, 15146086M, 15150029M, 15153004M, 151660012C, 151720052C, 151730131C, 151740007C, 151750019C, 151760011C, 151800048C,151880154M, Exp between 07/15/15-10/12/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
loss of potency