Drug product
fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3339.
D-0040-2017
Product summary
- Event
- Event 73925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1561 syringes
- Official record key
drug-enforcement:D-0040-2017
Official wording
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Code information: Lot Numbers: 15103037M, 15117042M, 15126027M, 15127049M, 15131003M, 15119043M, 15138050M, 15141033M, 15142056M, 15146040M, 15149039M, 151890299M, 151900220M, 151930019M, Exp between 07/15/15-10/12/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
loss of potency