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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm October 04, 2004
Date Posted October 28, 2004
Recall Status1 Terminated 3 on November 01, 2011
Recall Number Z-0060-05
Recall Event ID 30216
Product Classification Accessories, Soft Lens Products - Product Code LPN
Product Sterile Multi-Purpose Solution, NO RUB, for soft hydrophylic contact lenses. 12 fl oz. bottles.

Sold under the following brand names:
Family Dollar
HomeBest
HEB
Meijer
Food Lion
health PRIDE
Stop and Shop
Super G
sunmark
Brite-Life
Wegmans
Our Family
Healthy Generations
GoodSense
Winn Dixie
Finast
Western Family
K C Pharmaceuticals
Code Information All Codes
Recalling Firm/
Manufacturer
K C Pharmaceuticals Inc
3220 Producer Way
Pomona CA 91768-3915
For Additional Information Contact Sheila Solter
909-598-9499 Ext. 25
Manufacturer Reason
for Recall
Routine testing indicates product does not meet the expiration date in all cases.
FDA Determined
Cause 2
Other
Action Product is being recalled due to concern that the product does not meet it's expiration date. Firm sent letters to it customers requesting them to remove product from stores and to destroy it. A destruction form was sent with a request to mail it back.
Quantity in Commerce 2,252,664
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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