FDA Recalls
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May 12, 2010
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CLASS II
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Various Motrin
Products from McNeil Healthcare
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1) Motrin IB
(Ibuprofen) Tablets USP 200 mg, Pain Reliever/Fever
Reducer (NSAID), (a) 24-count bottle , NDC
50580-109-02, UPC 300450463029; (b) 50-count bottle ,
NDC50580-109-03, UPC 300450463036; (c) 100-count
bottle, NDC 50580-109-04, UPC 300450463043; (d)
100+25-count bottle, NDC 50580-109-29, UPC
300450463296; (e) 100+50-count bottle, NDC
50580-109-75, UPC 300450463753, OTC; 2) Motrin IB
(Ibuprofen) Tablets USP 200 mg Coated Caplets, Pain
Reliever/Fever Reducer (NSAID), (a) 24-count bottles,
NDC 50580-110-03, UPC 300450481030; (b) 24+6-count
bottle, NDC 50580-110-64, UPC 300450481641; (c)50-count
bottle, NDC 50580-110-02, UPC 300450481023; (d)
100-count bottle, NDC 50580-110-01, UPC 3004850481016;
(e) 100+25-count bottle, NDC 50580-110-95, UPC
300450481955; (f) 100+50-count bottle, NDC
50580-110-75, UPC 300450481757; (g) 225-count bottle,
NDC 50580-110-62, UPC 300450481627; (h) 300-count
bottle, NDC 50580-110-37, UPC 300450481375, OTC; 3)
Motrin Junior Strength for ages 6-11 (Ibuprofen)
Tablets, 100 mg, Pain Reliever/Fever Reducer (NSAID),
Grape Flavored Chewable Tablets, 24-count bottle, NDC
50580-909-24, UPC 300450909244, OTC; 4) Motrin Junior
Strength for ages 6-11 (Ibuprofen) Tablets, 100 mg,
Pain Reliever/Fever Reducer (NSAID), Easy-to-Swallow
Caplets, 24-count bottle, NDC 50580-498-24, UPC
300450498243, OTC; 5) Motrin Junior Strength for ages
6-11 (Ibuprofen) Tablets, 100 mg, Pain Reliever/Fever
Reducer (NSAID), Orange-Flavored Chewable Tablets,
24-count bottle, NDC 50580-207-24, UPC 300450494245,
OTC.
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Manufacturer:
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McNeil Healthcare,
LLC, Las Piedras, PR.
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Recalled
by:
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McNeil Consumer
Healthcare, Div. of McNeil-PPC, Inc., Fort Washington,
PA, by Web site posting on Nov. 6, 2009, press release
on Dec. 18, 2009 and letters on Nov. 9, 2009, Dec. 18,
2009 & Jan. 15, 2010. Firm-initiated recall is
ongoing.
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Distribution:
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Nationwide, Puerto
Rico, Canada, Uruguay, Fiji, Dominican Republic,
Trinidad, Guatemala, Jamaica, Guam, and UAE; 11,728,152
bottles.
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Reason:
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Chemical
Contamination: The product recall was initiated after
identifying an uncharacteristic smell and taste
associated with the presence of a chemical called
2,4,6,-tribromoanisole. The source of this chemical is
believed to be from the breakdown of a chemical
compound used to treat the wood pallets used for the
transportation and storage of packaging
materials.
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Recall
numbers:
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D-510/514-2010.
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DVM Hand
Cleanser
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Foaming Hand
Cleanser, 0.375% triclosan, 18-fl. oz. bottles and
1-gallon jugs, OTC only, (a) 18-fl. oz. bottles (NDC
59130-161-32), and (b) 1-gal. jugs (NDC
59130-161-05).
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Manufacturer:
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TEVA Animal Health
Inc., Saint Joseph, MO.
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Recalled
by:
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Manufacturer, by
letters dated Sept. 4, 2009 and Oct. 26, 2009.
Firm-initiated recall is ongoing.
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Distribution:
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Nationwide; 44,862
bottles.
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Reason:
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cGMP Deviation: The
product was not manufactured in conformance with
GMPs.
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Recall
number:
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D-518-2010.
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