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
Issuing Agency
FDA CDER
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.
What to do if you're affected
- →Check your pantry and refrigerator for the recalled product using the lot numbers and UPCs in the notice.
- →If you or a household member has a known allergy to the undeclared ingredient, discard the product or return it to the store for a full refund.
- →If you consumed the product and had an allergic reaction, seek medical attention.
- →If you carry an epinephrine auto-injector and have recently eaten the product, keep it accessible and monitor for symptoms.
- →Report any allergic reactions to the FDA at 1-800-FDA-1088.
About the FDA CDER
This recall was issued by or conducted in cooperation with the FDA's Center for Drug Evaluation and Research (CDER), which oversees prescription and over-the-counter medications sold in the United States. Drug recalls may be initiated voluntarily by the manufacturer or at FDA's request after a quality problem is identified through manufacturer testing, FDA inspection, or adverse event reports. Recalls are classified by severity: Class I involves products that may cause serious injury or death; Class II and III involve lower levels of risk. Do not stop a prescription medication due to a recall without first consulting your doctor or pharmacist.
View all FDA CDER recalls →Opens the official government source. Always refer to official sources for the most current information.