Drug product
Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017.
D-0520-2016
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 72716
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 4005 bottles, b) 104 bottles
- Official record key
drug-enforcement:D-0520-2016
Official wording
Reason: Failed Dissolution Specification
Code information: Lot #: C150065; C150064, Exp 6/16
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specification