FDA Drugs recall ·
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL… recall
Read the official FDA notice ↗
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.
Why was it recalled?
Failed Stability Specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 402805, 407596, Exp Date: 08/2026.
Distribution
US Nationwide.
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0551-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.