Drug product
midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3356.
D-0075-2017
Product summary
- Event
- Event 73925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26079 syringes
- Official record key
drug-enforcement:D-0075-2017
Official wording
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Code information: Lot Numbers: 151170045M, 151170084M, 151170093M, 15117084M, 151180080M, 15118092M, 15118094M, 15119054M, 15120072M, 15121093M, 151240093M, 151240094M, 151240099M, 15124074M, 151250094M, 15126044M, 15126079M, 15126080M, 15127097M, 15127098M, 15128112M, 151310092M, 151310103M, 151310105M, 15131028M, 151320099M, 15133012M, 15133081M, 15134068M,15134069M, 151380068M, 151380106M, 151380112M, 151390138M, 15139090M, 15140088M, 15140089M, 15141045M, 15141074M, 15141075M, 151450030M, 151450032M, 151460097M, 15146083M, 15146087M, 15149001M, 15149005M, 15149118M, 15149119M, 15150104M, 15152056M, 151720012M, 151730078M, 151730138M, 151740019M, 151740141M, 151740143M, 151890127M, 151890128M, 151890305M, 151900021M, 151900022M, 151900140M, 151930073M, 151930171M, 151930173M, Exp between 07/15/15-10/12/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
loss of potency