Drug product
midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3196.
D-0073-2017
Product summary
- Event
- Event 73925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1700 syringes
- Official record key
drug-enforcement:D-0073-2017
Official wording
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Code information: Lot Numbers: 15124046M, 15125056M, 15127070M, 15127073M, 15138054M, 15147055M, 15149049M, 151880314M, 151890307M, Exp between 07/15/15-10/12/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
loss of potency