Drug product
morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3119.
D-0077-2017
Product summary
- Event
- Event 73925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 935 syringes
- Official record key
drug-enforcement:D-0077-2017
Official wording
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Code information: Lot Numbers: 15117038M, 151200111M, 15126052M, 15127038M, 15131015M, 15134028M, 15134031M, 15135049M, 151380104M, 15139033M, 15139063M, 151410121M, 15146038M, 15147041M, 15149045M, 15152036M, 151730212M, 151890291M, 151930131M, Exp between 07/15/15-10/12/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
loss of potency