Recall: D-0162-2020
Class III - Minor Violations
Class IIIClassification
2019-10-17Initiated
TerminatedStatus
Sandoz IncFirm
Product
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, NDC 61314-630-06
Reason
Labeling: Incorrect or missing package insert.
Distribution
Nationwide in the U.S.
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.