Sandoz Inc: 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. P

Is my product affected?

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 NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

Check against the official notice below — it lists the full affected range.

What happened

Sandoz Inc. is recalling Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension in 5 mL bottles due to incorrect or missing package inserts. The recall affects 346,929 bottles distributed nationwide in the U.S., with multiple lot numbers and expiration dates ranging from October 2019 through May 2021.

The recall record does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Labeling: Incorrect or missing package insert.

Details from the source

Reason for recall: Labeling: Incorrect or missing package insert. Distribution: Nationwide in the U.S. Quantity: 346,929 bottles 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.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, 3.5 g tube, Rx only MFG: Sandoz, NDC 61314-631-362022-04-13
• 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.2019-10-17
• Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose, Rx only, Mfd. for: Wilshire Pharmaceuticals, Inc. Atlanta, GA 30328. NDC 52536-625-012019-09-27
• Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-92019-09-27
• Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No.: B-25, MIDC, Shendra Aurangabad - 431210, Maharashtra, India Manufactured for: Glenmark Pharmaceuticas Inc. USA Mahwah, NJ 074302019-11-15

All FDA (Drug enforcement) recalls