Drug product
midazolam HCl, 1 mg per mL (3 mg per 3 mL), in 0.9% Sodium Chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product Code 2R3351.
D-0074-2017
Product summary
- Event
- Event 73925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4058 syringes
- Official record key
drug-enforcement:D-0074-2017
Official wording
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Code information: Lot Numbers: 15124077M, 15126077M, 15128005M, 15131033M, 15133007C, 15133080M, 15135013C, 15138066M, 15139013C, 15141044M, 15154009C, 15160005C, 151740043C, 151800047C, 151900147M, Exp between 07/15/15-10/12/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
loss of potency