Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1014-68
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 Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Reason Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Reason Failed Dissolution Specifications
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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