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-607-2013
Product summary
- Firm
- Pfizer Inc
- Event
- Event 65324
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,410 botlles
- Official record key
drug-enforcement:D-607-2013
Official wording
Reason: Failed Dissolution Specification
Code information: Lot #: a) C120138, Exp 07/13; b) C120137, Exp 07/13
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specification