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Terminated

Equate Muti-Purpose Solution, For Soft Contact Lenses, Sterile, 12 Fl oz. (355 mL), Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716 Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses.

FDA Recall Z-3042-2011 · Posted 2011-08-19

Recalling FirmBausch & Lomb Inc
Recall StatusTerminated
Product CodeLYL
Date Initiated2011-06-30
Date Terminated2011-11-16
Product Quantity1200 bottles

Reason for Recall

Muti-purpose solution bottles, lot GC1107 were packaged in a carton that was marked with an incorrect lot code and expiration date.

Firm Action

Bausch & Lomb Inc. notified the affected customer via teleconference and e-mail on June 30, 2011. The e-mail describes the product, problem, and actions to be taken by the customer. The customer was instructed to hold and stop shipments of any inventory of the affected product. An official recall was initiated with the customer on July 8, 2011 via e-mail and teleconference. Customer was asked to review their inventory and store returns, and send any of the affected product to Bausch & Lomb Returns Dept., 130 Commerce Drive, Greenville, SC 29615.

Root Cause

Packaging

Distribution Pattern

Distribution-in the state of AK only

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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