Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Dissolution Specifications
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.
Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only, Distributed by Parke-Davis Division of Pfizer Inc., NY, NY 10017, NDC 0071-1029-01
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.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Failed Dissolution Specifications
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Superpotent Drug and Subpotent Drug: potency failures obtained
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