Food, drugs, devices › Bausch & Lomb, Inc.

Drug recall: Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incor

FDA enforcement event 61964 · Class II · initiated 6 Jul 2011 · status Terminated · terminated 24 Sep 2012

DrugVoluntary: Firm initiated1 product recordTampa, FL

FDA enforcement event 61964 is a drug recall by Bausch & Lomb, Inc. of Tampa, FL, initiated 6 Jul 2011 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 59% of the 22 drug enforcement events initiated in 2011 carry the same class.

Status: Terminated, terminated 24 Sep 2012. Initiation: voluntary: firm initiated. Bausch & Lomb, Inc. has 9 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Bausch & Lomb, Inc., Tampa, FL.

Reason for recall

"Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulose Lubricant Opthalmic Solution 1% (15 mL). Product was found to be OOS for Antimicrobial Effectiveness testing (AET) at the 12 month stability time point."

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1370-2012	Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incorporated, Tampa, FL 33637, NDC 24208-280-15	59,777 bottles	Class II	Terminated	20 Jun 2012

Context

59%of 2011 drug events are Class II22 events that year

1product record in this eventfirm median: 1

9events on this register for the firm

Other enforcement events for Bausch & Lomb, Inc.

Initiated	Product (first record)	Type	Class	Records
8 Aug 2018	Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.	Device	Class II	13
6 Jun 2017	NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 mL) metered spray pum	Drug	Class II	1
12 Oct 2016	Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies fr	Device	Class II	1
18 Jan 2016	Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL B	Drug	Class III	3
17 Aug 2015	Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637	Drug	Class II	1
4 Nov 2014	Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY	Device	Class II	3
10 Apr 2014	Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sampl	Drug	Class II	2
31 Aug 2012	Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the em	Device	Class II	1

All 9 events for Bausch & Lomb, Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulose Lubricant Opthalmic Solution 1% (15 mL). Product was found to be OOS for Antimicrobial Effectiveness testing (AET) at the 12 month stability time point."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 24 Sep 2012. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.