AbbVie Inc. — Class III: PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only
AbbVie Inc. has initiated a Class III recall for PRED MILD (prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL) due to failed stability specifications.
This recall affects AbbVie Inc., its subsidiary Allergan, Inc., and healthcare providers or distributors handling NDC 11980-174-10. It impacts personnel in stability testing, quality control, and supply chain management.
A Class III designation indicates that the use of or exposure to the product is not likely to cause adverse health consequences. However, the failure to meet stability specifications suggests potential issues in the manufacturing process or shelf-life validation for this sterile ophthalmic suspension, which may necessitate a review of stability monitoring protocols for similar formulations.
QA and stability testing teams should review retention samples and stability data for related ophthalmic suspensions to ensure ongoing compliance with USP specifications throughout the labeled shelf life. Inventory managers should identify and sequester affected NDC 11980-174-10 lots if currently held in stock.
Class III. Reason: Failed Stability Specifications. Product: PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.. Firm: AbbVie Inc. (North Chicago IL United States). Status: Ongoing.
Open in openFDA / FDA.gov