FDA Recalls &
Court Actions
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Sept. 20,
2006
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CLASS
II
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Amantadine Hydrochloride Capsules
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USP, 100
mg; single soft gelatin capsule unit dose blister
packs, 10 sheets of 10 unit dose capsules per carton;
NDC # 51079-481-20, Lot: 6B943, Exp. 08/07.
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Manufacturer:
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UDL
Laboratories, Inc., Rockford, IL.
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Recalled
by:
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Manufacturer, by letter dated Aug. 14, 2006.
Firm-initiated recall is ongoing.
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Distribution:
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Nationwide
including PR; 3,587 unit cartons were
distributed.
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Reason:
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Failed USP
content uniformity requirements.
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Recall
number:
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D-364-6.
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CLASS
III
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Premarin
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Conjugated
estrogens tablets, USP, 0.9 mg, bottles of 100
tablets, Rx only, NDC 0046-0864-81 (old NDC # - old
formulation), Lot: B17989, exp. 6/07.
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Manufacturer:
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Wyeth
Pharmaceuticals, Inc., Rouses Point, NY.
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Recalled
by:
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Manufacturer, by letter dated Aug. 28, 2006.
Firm-initiated recall is ongoing.
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Distribution:
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Nationwide;
97,301 units were distributed.
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Reason:
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Dissolution
failure: failed USP dissolution test
requirement.
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Recall
number:
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D-363-6.
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Uritact-EC Tablets; Prosed/DS
Tablets; Prosed EC tablets
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(a) Each
enteric coated tablet contains methenamine 81.6 mg,
phenyl salicylate 36.2 mg, methylene blue 10.8 mg,
benzoic acid 9.0 mg, atropine sulfate 0.06 mg,
hyoscyamine sulfate 0.06 mg; 90 tablets, Rx only, NDC
60258-517-09; (b) each tablet contains methenamine
81.6 mg, phenyl salicylate 36.2 mg, methylene blue
10.8 mg, benzoic acid 9.0 mg, atropine sulfate 0.06
mg, hyoscyamine sulfate 0.06 mg; Rx only. 100 tablet
bottles, NDC 0076-0108-03; 4 tablet physician
samples, NDC 0076-0108-02; (c) each enteric coated
tablet contains methenamine 81.6 mg, phenyl
salicylate 36.2 mg, methylene blue 10.8 mg, benzoic
acid 9.0 mg, atropine sulfate 0.06 mg, hyoscyamine
sulfate 0.06 mg; Rx only, 90 tablet bottles, NDC
15456-0909-90; (d) each enteric coated tablet
contains methenamine 81.6 mg, phenyl salicylate 36.2
mg, methylene blue 10.8 mg, benzoic acid 9.0 mg,
atropine sulfate 0.06 mg, hyoscyamine sulfate 0.06
mg; Rx only, pouch containing 2 tablets, NDC
0076-0909-02. (a) Lot 053104 (exp. 7/08); (b) Lots:
043151, 043617, 044513; (c) Lots: 042253, 043616,
044512, 053615; (d) Lots: 042253, 043616, 044512,
053615.
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Manufacturer:
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Contract
Pharmacal Corporation, Hauppauge NY.
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Recalled
by:
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Manufacturer, by letter dated July 18, 2006.
Firm-initiated recall is ongoing.
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Distribution:
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Nationwide;
Uritact-EC: 5,874 bottles; Prosed/DS: 9,598 bottles;
Prosed-EC: 27,709 bottles & 20,016 displays (12 x
2 tabs) were distributed.
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Reason:
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No testing
was performed for hyoscyamine sulfate and atropine
sulfate ingredients in these products to determine
satisfactory conformance to specifications and to
verify stability of these products over labeled shelf
life.
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Recall
numbers:
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D-359/362-6.
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EDITORS' NOTE:
Tabulation prepared from information provided by
FDA. The agency has three classes of recalls.
Class I - violative product poses reasonable
probability of serious adverse health consequences or
death; Class II - violative product may cause
temporary or medically reversible adverse health
consequences; probability of serious consequences
remote; Class III - violative product not
likely to cause adverse health consequences. Editors
of "The Pink Sheet" appreciate hearing from any
company that would like to provide additional
information on any recall listed in a weekly
tabulation.
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