Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Dissolution Specification
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
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.
Compare with the code on your package — it is the most precise check available.
Drug: Disopyramide
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Labeling: Label Mixup: DISOPYRAMIDE PHOSPHATE, Capsule, 150 mg may have potentially been mislabeled as the following drug: THYROID, Tablet, 30 mg, NDC 00456045801, Pedigree: AD65323_1, EXP: 5/29/2014.
Failed Dissolution Specification
Lack of Assurance of Sterility
Lack of Assurance of Sterility.
Lack of Assurance of Sterility.
Subpotent drug
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