Drug product
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0605-2016
Product summary
- Event
- Event 72177
- Status
- Terminated
- Classification
- Class II
- Quantity
- 378
- Official record key
drug-enforcement:D-0605-2016
Official wording
Reason: Stability data does not support expiry.
Code information: All lots with expiration dates up to 11/17/2015
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Stability data does not support expiry