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.
FDA recall notice · announced June 26, 2013 · Pfizer
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
The 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.
Reason for recall
Failed Dissolution Specification
Notes
Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #: a) C120138, Exp 07/13; b) C120137, Exp 07/13
Quantity: 5,410 botlles
Status: Terminated
Products in this recall event:
- 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. (D-607-2013)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.