Drug product
Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228.
D-0032-2017
Product summary
- Event
- Event 73925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 210 syringes
- Official record key
drug-enforcement:D-0032-2017
Official wording
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Code information: Lot Numbers: 151000045M, 15127040M, 15133026M, 15141029M, 151930078M, 15132103M, Exp between 07/15/15-10/12/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
loss of potency