November 21, 2002
Qualis Has Recalled Pyrethrin Lice Treatment
(SafetyAlerts) -
The Food and
Drug Administration (FDA) has released the following information.
PRODUCT
Pyrethrin Lice Treatment (Piperonyl Butoxide 4% and Pyrethrum Extract
(equivalent to 0.33% Pyrethrins), Kinray Preferred Plus brand, A Creme
Rinse Application, 2 fl. oz. (59 mL) bottles, single and twin packs.
Recall # D-054-3.
CODE
2F15A, exp. June 2004 (single unit)
2G02A, exp. July 2004 (twin pack)
2G25D, exp. July 2004 (twin pack).
RECALLING FIRM/MANUFACTURER
Qualis, Inc., Des Moines, IA, by telephone on October 28, 2002.
Firm initiated recall is ongoing.
REASON
Mislabeling; one active ingredient is incorrectly declared on the bottle
label as Permethrin rather than correctly as Pyrethrin.
VOLUME OF PRODUCT IN COMMERCE
504 single units and 384 twin packs; 118 single packs and 245 twin
packages have been quarantined at the own-label distributor awaiting
return to Qualis.
DISTRIBUTION
NY. |
