Bausch & Lomb Boston Conditioning Solution, Original Formula, Bausch & Lomb Incorporated, Rochester, NY 14609. The product is packed in 1 fl oz (30 mL), 3 fl oz (90 mL), 3.5 fl oz (105 mL) and 4 fl oz (120 ml) bottles.
FDA Recall Z-0553-2010 · Posted 2009-12-22
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Recalling FirmBausch & Lomb Inc
Recall StatusTerminated
Product CodeMRC
Date Initiated2009-10-30
Date Terminated2012-08-29
Product Quantity159,672 bottles
Reason for Recall
The product failed to meet Out of Specification shelf life at the 9 months time point. This could result in increased risk of an ocular infection, especially in the presence of other contributing or risk factors.
Firm Action
Consignees were notified by mail on/about 11/06/2009. All consignees were asked to review their inventory, and return any of the affected products to Stericycle Pharmaceutical Services. A Business Reply Card was included to be returned via US mail within 5 days. A packing slip was provided to be affixed to a pre-paid USP shipping label for return.
Root Cause
Other
Distribution Pattern
U.S. Nationwide, Canada and Hong Kong
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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