Class III · Low risk
Lotemax (loteprednol etabonate ophthalmic gel 0.5%)
Failed Stability Specifications: Out of specification for viscosity.
Murocel (methylcellulose)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incorporated, Tampa, FL 33637, NDC 24208-280-15
Affected NDC
24208-0280-15
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Bausch & Lomb, Inc.
- NDC code
- 24208-280-15
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1370-2012 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Bausch & Lomb, Inc.
All 2011 recalls
Class II · Moderate risk
NasalCrom (cromolyn sodium)
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Class III · Low risk
Tropicamide Ophthalmic Solution USP
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk
Tropicamide Ophthalmic Solution USP
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Other sterility / contamination recalls from 2011
All sterility / contamination recalls
Class II · Moderate risk
ChloraPrep with Tint
Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Lack of Assurance of Sterility
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