Drug product
fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.
D-0035-2017
Product summary
- Event
- Event 73925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8955 syringes
- Official record key
drug-enforcement:D-0035-2017
Official wording
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Code information: Lot Numbers: 15118074M, 15120007M, 15124007M, 15127060M, 15132006M, 15132039M, 15138059M, 15139012M, 15139051M, 15140003M, 15141067M, 15146006M, 15148075M, 151730112M, 151730155M, 151740205M, 151880329M, 151930020M, 151930026M, Exp between 07/15/15-10/12/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
loss of potency