FDA Recalls & Court
Actions
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April 26, 2006
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CLASS
II
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Analpram HC Cream 2.5% and 1%;
L.M.X.5 Anorectal Cream
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(a)
Hydrocortisone acetate 2.5% and pramoxine HCl 1%, net
wt. 1 oz tube, Rx only, NDC 0496-0800-04; (b)
hydrocortisone acetate 2.5% and pramoxine HCl 1%,
professional sample, net wt. 3 gram tube, Rx only,
NDC 0496-0800-33; (c) lidocaine 5%, net wt. 15 gram
tube, OTC, NDC 0496-0883-15; (d) hydrocortisone
acetate 1% and pramoxine HCl 1%, net wt. 1 oz tube,
Rx only, NDC 0496-0778-04. Lots: (a) 04122A exp.
07/06, 04123A exp. 07/06, 04124A exp. 07/06, 04138A
exp. 08/06, 04139A exp. 08/06, 05042A exp. 02/07,
05044A exp. 02/07, 05058A exp. 03/07, 05059A exp.
03/07, 05060A exp. 03/07, 05068A exp. 03/07, 05079A
exp. 04/07, 05080A exp. 04/07, 05081A exp. 04/07,
05091A exp. 04/07, 05092A exp. 04/07, 05093A exp.
04/07, 05094A exp. 06/07, 05095A exp. 06/07, 05096A
exp. 08/07, 05173A exp. 08/07 and 05231A exp. 08/07;
(b) 05145A exp. 05/07, 05079B exp. 04/07, 05080B exp.
04/07, and 05081B exp. 04/07; (c) 04021A exp. 04/06
and 05085A exp. 04/08; (d) 04135A exp. 08/07, 04136A
exp. 08/07, 04186A exp. 11/07, 04189A exp. 11/07,
04190A exp. 11/07, 04191A exp. 11/07, 04201A exp.
12/07 and 04202A exp. 12/07.
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Manufacturer:
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Ferndale
Laboratories, Inc., Ferndale, MI.
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Recalled
by:
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Manufacturer, by letter dated March 24,
2006. Firm-initiated recall is ongoing.
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Distribution:
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Nationwide;
414,259 tubes.
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Reason:
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Reports of
adverse events: The firm redesigned the applicator
and, since the design change, patients have reported
being injured by the applicator upon use.
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Recall
number:
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D-231/234-6.
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Tizanidine Hydrochloride Tablets
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(a) 4 mg,
Rx only, NDC 0093-5160-51; (b) 2 mg, Rx only. Lots:
(a) 22765D exp. 3/06, 22766D exp. 3/06, 22767D exp.
3/06, 22609 exp. 3/06, 22610 exp. 3/06, 22762 exp.
4/06, 22763 exp. 4/06, 22764 exp. 7/06, 23241 exp.
7/06, 23242 exp. 7/06, 23348 exp. 8/06, 23349 exp.
8/06, 23739 exp. 9/06, 23740 exp. 9/06, 23854 exp.
11/06, 23963 exp. 12/06, 23964 exp. 1/07, 24077 exp.
2/07, 24369 exp. 2/07, 24454 exp. 2/07, 24626 exp.
4/07, and 24627 exp. 4/07; (b) 22791D exp. 4/06,
22792D exp. 4/06, 22793D exp. 4/06, 22805 exp. 4/06,
23745 exp. 9/06, 23965 exp. 10/06, 23966 exp. 1/07,
and 24375 exp. 3/07.
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Manufacturer:
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Teva
Pharmaceuticals, Sellersville, PA.
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Recalled
by:
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Manufacturer, by letter on/about March 20,
2006. Firm-initiated recall is ongoing.
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Distribution:
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Nationwide;
515,842 bottles.
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Reason:
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Dissolution
failure.
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Recall
number:
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D-229/230-6.
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CLASS III
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Methylphenidate Hydrochloride
Extended-Release Tablets
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USP, 20 mg,
CII, Rx only, 100 tablets, NDC 0591-3111-01, Lot
L5L1270, exp. 12/07.
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Manufacturer:
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Watson
Laboratories, Inc., Carmel, NY.
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Recalled
by:
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Watson
Laboratories, Inc., Corona, CA, by letter dated,
March 27, 2006. Firm-initiated recall is
ongoing.
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Distribution:
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Nationwide
and Puerto Rico; 4,993 bottles.
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Reason:
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Failed
dissolution specification; 3-month stability.
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Recall
number:
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D-235-6.
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