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.
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1370-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 6, 2011
- FDA report date
- Jun 20, 2012
- Quantity
- 59,777 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bausch & Lomb, Inc.
Original FDA data
Every field from FDA enforcement report D-1370-2012, exactly as published.
Show all FDA fields
- City
- Tampa
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 61964
- Address
- 8500 Hidden River Pkwy
- 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.
- Postal code
- 33637-1014
- Report date
- Jun 20, 2012
- Product type
- Drugs
- Recall number
- D-1370-2012
- Classification
- Class II
- Recalling firm
- Bausch & Lomb, Inc.
- Product quantity
- 59,777 bottles
- Termination date
- Sep 24, 2012
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 6, 2011
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jun 11, 2012