Drug product
lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL in a syringe, Rx only, PharMEDium, Product code 2R3343.
D-0091-2017
Product summary
- Event
- Event 73925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4400 syringes
- Official record key
drug-enforcement:D-0091-2017
Official wording
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Code information: Lot Numbers: 15118063M, 15119033M, 15124035M, 15132062M, 15135014C, 15138006M, 15146004M, 15147009C, 15152042M, 15155003C, 15160004C, 151680013C, 151730130M, 151900142M, 151950033M, Exp between 07/15/15-10/12/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
loss of potency