Drug product
glycopyrrolate, 0.2 mg per mL, 1 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3340.
D-0046-2017
Product summary
- Event
- Event 73925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1494 syringes
- Official record key
drug-enforcement:D-0046-2017
Official wording
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Code information: Lot Numbers: 15112008M, 15112040M, 15113024M, Exp between 07/15/15-10/12/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
loss of potency