Drug product
fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153.
D-0034-2017
Product summary
- Event
- Event 73925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4347 syringes
- Official record key
drug-enforcement:D-0034-2017
Official wording
Reason: Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.
Code information: Lot Numbers: 15100052M, 15103048M, 15104052M, 15118032M, 15127009M, 15127068M, 15134039M, 15135009M, 15135054M, 15140070M, 15147039M, 15148065M, 151900145M, 151930043M, Exp between 07/15/15-10/12/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent