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
Reported: November 6, 2019 Initiated: October 17, 2019 #D-0162-2020
Product Description
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 for Recall
Labeling: Incorrect or missing package insert.
Details
- Recalling Firm
- Sandoz Inc
- Units Affected
- 346,929 bottles
- Distribution
- Nationwide in the U.S.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sandoz Inc. Units affected: 346,929 bottles.
Why was this product recalled? ▼
Labeling: Incorrect or missing package insert.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 6, 2019. Severity: Low. Recall number: D-0162-2020.
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