Drug product
atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3324.
D-0025-2017
Product summary
- Event
- Event 73925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4407 syringes
- Official record key
drug-enforcement:D-0025-2017
Official wording
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Code information: Lot Numbers: 15146085M, 15147088M, 15149011M, 15149109M, 15150093M, 151730001M, 151740139M, 151900018M, 151910014M, Exp between 07/15/15-10/12/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
loss of potency