Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31)…
Reason Failed Dissolution Specification
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Dissolution Specification
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Dissolution Specification
Reason Labeling: Label Mixup: DISOPYRAMIDE PHOSPHATE, Capsule, 150 mg may have potentially been mislabeled as the following drug: THYROID, Tablet, 30 mg…
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