Status
Terminated
Drug Enforcement D-1370-2012
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.
Classification
Class II
Report Date
June 20, 2012
Termination Date
September 24, 2012
Product Information
- 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
- Product quantity
- 59,777 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Bausch & Lomb, Inc.
- Address
-
8500 Hidden River Pkwy
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1370-2012
- Event ID
- 61964
- Recall initiation date
- July 6, 2011
- Center classification date
- June 11, 2012
- Code info
- 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.
- More code info
- —