Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per car...

FDA Drug Recall #D-1410-2014 — Class II — April 10, 2014

Recall Summary

Recall Number D-1410-2014
Classification Class II — Moderate risk
Date Initiated April 10, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bausch & Lomb, Inc.
Location Tampa, FL
Product Type Drugs
Quantity a) 4,165 tubes; b) and c) 844,879 tubes

Product Description

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 carton, NDC 24208-385-56, UPC 3 24208-385-56 3; Bausch & Lomb Incorporated, Tampa, FL 33637.

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 Pattern

Nationwide, Puerto Rico, Canada, and Hong Kong.

Lot / Code Information

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

Other Recalls from Bausch & Lomb, Inc.

Recall # Classification Product Date
D-0899-2017 Class II NasalCrom (cromolyn sodium) Nasal Spray, USP, 5... Jun 6, 2017
D-0645-2016 Class III Cyclopentolate Hydrochloride Ophthalmic Solutio... Jan 18, 2016
D-0646-2016 Class III Tropicamide Ophthalmic Solution USP, 0.5%, Pack... Jan 18, 2016
D-0647-2016 Class III Tropicamide Ophthalmic Solution USP, 1%, Packag... Jan 18, 2016
D-1349-2015 Class II Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bo... Aug 17, 2015

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.