PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie co
Manufacturer / Brand: AbbVie Inc.
Reason for Recall
Failed Stability Specifications
Date Issued
Category
Medications
Status
voluntary
About Medications recalls
Drug recalls in the United States are overseen by the FDA's Center for Drug Evaluation and Research. They may be initiated voluntarily by the manufacturer or requested by the FDA when contamination, potency issues, or labeling errors are identified. Class I drug recalls — the most serious — involve situations where the product may cause serious injury or death. Before stopping a prescription medication due to a recall, contact your pharmacist or prescriber: for many medications, abrupt discontinuation carries its own risks. Your pharmacy can usually arrange an emergency replacement from an unaffected lot or an alternative manufacturer at no additional cost.
What to do if you're affected
- →Stop taking the medication if it matches the recalled lot number.
- →Contact your doctor or pharmacist before stopping any prescription.
- →Return the product to your pharmacy for a refund or replacement.
- →Call the manufacturer's hotline listed on the official recall notice.
About undeclared allergen recalls
Undeclared allergen recalls occur when a food product contains one or more of the major food allergens — peanuts, tree nuts, milk, eggs, wheat, soy, fish, shellfish, or sesame — without listing them on the label. For most consumers this is a labeling compliance issue, but for individuals with food allergies or intolerances it can cause reactions ranging from hives and swelling to anaphylaxis, a severe and potentially life-threatening reaction.
⚠ If you have a known allergy to the undeclared ingredient and have consumed the product, monitor for symptoms. If you carry an epinephrine auto-injector, keep it accessible. Consult your allergist if you are unsure.
Opens the official government source. Always refer to official sources for the most current information.