Drug product
Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incorporated, Tampa, FL 33637, NDC 24208-280-15
D-1370-2012
Product summary
- Event
- Event 61964
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59,777 bottles
- Official record key
drug-enforcement:D-1370-2012
Official wording
Reason: 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.
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.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility