Bausch & Lomb, Inc.: Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sample, NDC 24208-385-01, UPC 3 24208-385-01 2; b) 1/8 oz. (3.5

Is my product affected?

Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sample, NDC 24208-385-01, UPC 3 24208-385-01 2; b) 1/8 oz. (3.5 g) tube per carton, NDC 24208-385-55, UPC 3 24208-385-55 5; and c) 1/4 oz. (7 g) Twin Pack, Two 1/8 oz. (3.5 g) tubes per

• Brand MURO 128

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

What happened

Bausch & Lomb, Inc. is recalling Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, distributed nationwide, in Puerto Rico, Canada, and Hong Kong. The recall affects approximately 4,165 professional sample tubes of 1 gram and 844,879 tubes of 1/8 ounce due to crystallization and crystal precipitate formation in the product. Affected consumers have reported a gritty, sand-like feeling in the eye when using the ointment.

The recalled product includes multiple lot numbers with expiration dates ranging from June 2014 through October 2016. The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.

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

Hazard

Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.

Details from the source

Reason for recall: Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye. Distribution: Nationwide, Puerto Rico, Canada, and Hong Kong. Quantity: a) 4,165 tubes; b) and c) 844,879 tubes Lot/code info: Lot #: a) 179271, Exp 08/14; b) and c) 146791, 146932, Exp 06/14; 151221, 151922, Exp 09/14; 159102, Exp 02/15; 160912, Exp 03/15; 162422, Exp 04/15; 163641, 05/15; 166592, Exp 07/15; 169273, Exp 09/15; 170482, Exp 10/15; 174882, Exp 12/15; 176932, Exp 01/16; 179272, Exp 02/16; 182772, Exp 05/16; 186722, Exp 07/16; 190182, Exp 09/16; and 191631, Exp 10/16

Source

Official record: FDA (Drug enforcement) ↗

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

Related recalls

• Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4699-302014-04-02
• Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794-018-06, SigmaPharm Laboratories, LLC, Bensalem, Pa.2014-04-22
• Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister card, b) NDC 0597-0075-41, 30 Spiriva capsules per blister card, Manufactured by:2014-03-27
• PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 mL), Distributed by Medtech Products, Inc., Tarrytown,NY ---- UPC 8148320135442014-04-25
• PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and Phenylephrine HCl 2.5 mg) and NIGHTTIME MULTI-SYMPTOM Cold (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL oz (118 mL) bottles, one each of DAYTIME MULTI-SYMPTOM Cold, Distributed by Med2014-04-25

All FDA (Drug enforcement) recalls