Healing Labs Rite Choice Pregnancy Test Kit, packed in a cellophane display box, containing one test strip and materials for one test, and labeled in part ***Distributed by Core Brands, 1301 Wicomico St Baltimore, MD 21230 USA***Made in China***UPC 087399430205***. Packed 48 boxes/case.
FDA Recall Z-1042-05 · Posted 2005-07-22
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Recalling FirmCore Brands
Recall StatusTerminated
Product CodeLCX
Date Initiated2005-06-22
Date Terminated2005-11-16
Product Quantity2710 cases
Reason for Recall
Home pregnancy test kit lacks 510k approval and cannot be assured as safe and effective.
Firm Action
The recalling firm notified distributors by phone on 06/17/05 to hold product and followed with a letter and fax to distributors and direct account retailers on 06/21/05. Notification instructed distributors and retailers to discontinue selling the product and return product. Distributors were requested to notify all of their consignees with the 'retailer alert' notification provided.
Root Cause
Other
Distribution Pattern
Product was sold to distributors and retailers in MI, NY, MD, MA, PA, NJ and RI..
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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