Drug product
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3321.
D-0089-2017
Product summary
- Event
- Event 73925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6970 syringes
- Official record key
drug-enforcement:D-0089-2017
Official wording
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Code information: Lot Numbers: 151120168M, 151120169M, 15112027M, 15112096M, 15113021M, 15113080M, 15113081M, 15113082M, 15113083M, 15113084M, 15113085M, 15113086M, 15113087M, 15113088M, Exp between 07/15/15-10/12/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
loss of potency