Recalls / Class II
Class IID-1370-2012
Product
Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incorporated, Tampa, FL 33637, NDC 24208-280-15
- Affected lot / 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.
Why it was recalled
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.
Recalling firm
- Firm
- Bausch & Lomb, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 8500 Hidden River Pkwy, Tampa, Florida 33637-1014
Distribution
- Quantity
- 59,777 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2011-07-06
- FDA classified
- 2012-06-11
- Posted by FDA
- 2012-06-20
- Terminated
- 2012-09-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1370-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.