Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0910-05

Lover brand lubricated latex condoms in various presentations, Nuevo Innovations, Farmingdale, NY ; item...

Harmony Brands LLC / initiated 2005-03-25 / Terminated

Harmony Brands Llc began a recall of Lover brand lubricated latex condoms in various presentations, Nuevo Innovations, Farmingdale, NY ; item numbers 29042, 29044, 29045, 29047, 29095, 29095D... on . The reason FDA records is "Lack of assurance of safety and efficacy; products are from unknown sources". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0910-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Harmony Brands LLC
Product
Lover brand lubricated latex condoms in various presentations, Nuevo Innovations, Farmingdale, NY ; item numbers 29042, 29044, 29045, 29047, 29095, 29095D, 29096, 29097, 29111, 29112, 29145, 29146, 29147 and 29148.
Reason for recall
Lack of assurance of safety and efficacy; products are from unknown sources.
FDA root cause
Other
Action
Harmony issued a press release on 3/25/05. Consignees to the retail level were notified by letter beginning on 3/28/05.
Quantity in commerce
unknown.
Distribution
United States .
Product codes and lots
All lots.