D-1370-2012 Class II Terminated
FDA drug recall D-1370-2012 was initiated by Bausch & Lomb, Inc. on Jul 6, 2011 and is designated Class II. 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… The recall status is terminated (terminated Sep 24, 2012). Affected quantity: 59,777 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 20, 2012
- Initiation Date
- Jul 6, 2011
- Termination Date
- Sep 24, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59,777 bottles
Product Description
Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incorporated, Tampa, FL 33637, NDC 24208-280-15
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 Pattern
Nationwide
Code Information
Lot#: 467061, Exp 09/11; 487551, Exp 11/11; 507521, Exp 1/12; 548051, Exp 5/12; 132171, Exp 8/12; 136571, Exp 11/12; 140181, Exp 1/13.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1370-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026