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.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1013-68
Compare with the code on your package — it is the most precise check available.
Drug: Pregabalin
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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.
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Failed Dissolution Specifications
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lack of Assurance of Sterility
Lack of Assurance of Sterility.
Lack of Assurance of Sterility.
Subpotent drug
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