Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina.
Reported: November 6, 2019 Initiated: October 17, 2019 #D-0161-2020
Product Description
Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina.
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? ▼
Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina.. 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-0161-2020.
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