B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc., Melvindale, MI; Items 28030 (case of 48 kits) and 28031 (case of 144 kits).
FDA Recall Z-0909-05 · Posted 2005-06-21
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Recalling FirmHarmony Brands Llc
Recall StatusTerminated
Product CodeLCX
Date Initiated2005-03-25
Date Terminated2007-04-17
Product Quantityunknown.
Reason for Recall
Lack of assurance of safety and efficacy; products are from unknown sources.
Firm Action
Harmony issued a press release on 3/25/05. Consignees to the retail level were notified by letter beginning on 3/28/05.
Root Cause
Other
Distribution Pattern
United States .
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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