B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc., Melvindale, MI; Items 28030 (case of 48 ki
FDA device recall Z-0909-05 · posted 2005-06-21 · Terminated
Recall details
- Recalling firm
- Harmony Brands Llc
- Reason for recall
- Lack of assurance of safety and efficacy; products are from unknown sources.
- Action taken
- 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
- Status
- Terminated
- Product code
- LCX
- Quantity affected
- unknown.
- Distribution
- United States .
- Date initiated
- 2005-03-25
- Date posted
- 2005-06-21
- Date terminated
- 2007-04-17
- Location
- Oak Park, MI
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