Bausch & Lomb Recalls Murocel Lubricant Ophthalmic Solution Due to Sterility Concerns
Bausch & Lomb is recalling 59,777 bottles of Murocel Lubricant Ophthalmic Solution because the product failed antimicrobial effectiveness testing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Bausch & Lomb, Inc. is recalling 59,777 bottles of Murocel (methylcellulose) Lubricant Ophthalmic Solution (USP, 1%), 15 mL bottles. The recall involves seven specific lots distributed nationwide.
The recall was initiated because the product was found to be out of specification for Antimicrobial Effectiveness testing at the 12-month stability time point. This indicates a lack of assurance of sterility for the affected units.
Consumers should check their bottles for the following lot numbers and expiration dates: 467061 (Exp 09/11), 487551 (Exp 11/11), 507521 (Exp 1/12), 548051 (Exp 5/12), 132171 (Exp 8/12), 136571 (Exp 11/12), and 140181 (Exp 1/13). If you have a bottle with one of these lot numbers, you should stop using it and contact Bausch & Lomb or your healthcare provider for instructions on how to return the product.
The recalled product
- Product
- Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incorporated, Tampa, FL 33637, NDC 24208-280-15
- Manufacturer
- Bausch & Lomb, Inc.
- Category
- Drug — Ophthalmic Solution
- Affected units
- 59,777
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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
Distributed nationwide across the United States.
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