Apotex Corp. — Class II: Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Ap
Apotex Corp. has initiated a Class II recall for Paroxetine Extended-Release Tablets (37.5mg, 30-count bottles) due to failure to meet dissolution specifications. The recall, involving NDC 60505-1318-3, is currently classified as ongoing.
This recall affects Apotex Corp., Apotex Inc., and professionals involved in the manufacturing, quality control, and distribution of extended-release paroxetine products.
Dissolution failure in an extended-release dosage form is a significant quality defect that may impact the drug's pharmacokinetic profile, potentially leading to altered drug release rates and compromised therapeutic efficacy. For regulatory and QA professionals, this suggests a potential need to investigate manufacturing process controls or stability profiles for this specific formulation to prevent recurrence.
Quality units should review dissolution testing data and stability protocols for extended-release oral solids to ensure batch-to-batch consistency. Regulatory teams should monitor the status of NDC 60505-1318-3 and coordinate with supply chain partners to manage the ongoing recall process.
Class II. Reason: Failed dissolution specifications.. Product: Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-1318-3. Firm: Apotex Corp. (Weston FL United States). Status: Ongoing.
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