Recalls / Class III
Class IIID-0162-2020
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
- Brand name
- Neomycin And Polymyxin B Sulfates And Dexamethasone
- Generic name
- Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone
- Active ingredients
- Dexamethasone, Neomycin Sulfate, Polymyxin B Sulfate
- Route
- Ophthalmic
- NDC
- 61314-630
- FDA application
- ANDA062341
- Affected lot / code info
- Lot #s: 287880F, 287881F, Exp. 10/31/2019; 290555F, Exp. 11/30/2019; 293389F, Exp. 2/29/2020; 290556F, 290557F, 293386F, 293387F, Exp. 3/31/2020; 293388F, 293390F, Exp. 5/31/2020; 293391F, Exp. 6/30/2020; 293392F, Exp. 7/31/2020; 295342F, 298823F, Exp. 8/31/2020; 295344F, 295345F, 295346F, Exp. 10/31/2020; 295347F, 304496F, Exp. 11/30/2020; 298825F, Exp. 12/31/2020; 304495F, 304497F, Exp. 01/31/2021; 304963F, Exp. 3/31/2021; 304966F, Exp. 4/30/2021; 304964F, Exp. 5/31/2021.
Why it was recalled
Labeling: Incorrect or missing package insert.
Recalling firm
- Firm
- Sandoz Inc
- Manufacturer
- Sandoz Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- 346,929 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2019-10-17
- FDA classified
- 2019-10-28
- Posted by FDA
- 2019-11-06
- Terminated
- 2022-01-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0162-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.