Drug Enforcement D-022-2014

Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.

Status

Terminated

Classification

Class III

Report Date

December 4, 2013

Termination Date

November 4, 2014

Product Information

Product description
Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufactured by Novartis Consumer Health, Inc, Lincoln, NE / There are 7 different labels under which this product is packaged but the active ingredient is the same. 1) DOLLAR GENERAL LABEL: DG Health Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 60 tablet blister packs (UPC code: 300436122) and 30 tablet blister packs (UPC code: 300676122304). Distributed by Dolgencorp, LLC, Goodlettsville, TN. 2) FAMILY DOLLAR LABEL: Family Wellness Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 30 tablet blister packs (UPC code: 032251004292). Distributed by Family Dollar Services, Inc, Matthews, NC. 3) FAMILY DOLLAR LABEL Family Dollar Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 30 tablet blister packs (UPC code: 400910131502). Manufactured by Novartis Consumer Health, Inc, Lincoln, NE and Distributed by Family Dollar Services, Inc, Charlotte, NC. 4) TARGET LABEL: Allergy Relief Medication, loratadine, 10 mg/antihistamine, packaged in 10 tablet (UPC 300670675103), 15 tablet (UPC 300670668150), 30 tablet (UPC 300670675301), 40 tablet (UPC 300670675400), and 60 tablet (UPC 300670675004) blister packs. It is also packaged in 120 tablet (UPC 300670675127) and 180 tablet (UPC 300676255736) bottles. Dist. by Target Corporation, Minneapolis, MN. 5) PRIVATE LABEL: Loratadine 10mg, Antihistamine, packaged in 10 tablet (UPC 300670674106) and 30 tablet (UPC 300670674304) blister packs. Manufactured and Distributed by: Novartis Consumer Health, Inc., Lincoln, NE. 6) WALMART LABEL, Equate, Allergy Relief, Loratadine Tablets, 10 mg, Antihistamine, packaged in 10 tablet (UPC 681131739276) and 30 tablet (UPC 681131739283) blister packs. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR. 7) CVS LABEL: CVS Pharmacy, Allergy Relief, Loratadine 10mg/Antihistamine, packaged in 5 tablet (UPC 050428068595), 10 tablet (UPC 050428046784), 20 tablet (UPC 050428065747) (UPC 050428579350), and 30 tablet (UPC 050428046791) blister packs. Also packaged in 120 tablet (UPC 050428065822) and 365 tablet (UPC 050428160282) plastic bottles. Manufactured by: Novartis Consumer Health, Inc., Lincoln, NE, for: CVS Pharmacy, Inc., Woonsocket, RI.
Product quantity
11,846,608 blister packs
Reason for recall
Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Novartis Consumer Health
Address
10401 Hwy 6, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-022-2014
Event ID
66232
Recall initiation date
September 3, 2013
Center classification date
November 27, 2013
Code info
1) DG Health Allergy Relief 60 tablet packages: Lot 10114571, exp 4/14 and Lot 10114573, exp 5/14. 30 tablet packages lot and exp date: 10098129, 9/13; 10099649, 10/13; 10101302, 11/13; 10103516, 12/13; 10103517, 12/13; 10106238, 1/14; 10109436, 2/14; 10111296, 3/14; 10112222, 3/14 and 10114573, 5/14. 2) DG Health Allergy Relief Lot number and exp date: 10122379, 8/14. 3) Family Dollar Allergy Relief Lot number and exp date: 10098127, 9/13; 10098129, 9/13; 10099649, 10/13; 10099650, 10/13; 10101299, 11/13; 10101303, 11/13; 10103517, 12/13; 10106236, 1/14; 10106237, 1/14; 10107030, 2/14; 10109434, 2/14; 10109436, 2/14; 10109438, 2/14; 10109861, 3/14; 10109863, 2/14; 10112223, 3/14; 10116503, 5/14; 10116506, 6/14 and 10118377, 7/14. 4) Target Allergy Relief Lot number and exp date: 10 ct blister pack: 10098127, 9/13; 10103516, 12/13; 10106238, 1/14; 10109863, 2/14; 10111298, 3/14; 10111300, 3/14; 10118377, 7/14; 10122382, 10/14 and 10126772, 11/14. 15 ct blister pack: 10101299, 11/13, 10109434, exp 2/14 and 10103515, 12/13. 30 ct blister pack: 10098127, 9/13; 10099646, 9/13; 10099648, 10/13; 10101298, 11/13; 10101303, 11/13; 10106234, 12/13; 10106235, 12/13; 10106237, 1/14; 10107028, 1/14; 10109437, 2/14; 10109864, 2/14; 10112221, 3/14; 10114570, 4/14; 10114571, 4/14; 10114572, 4/14; 10116505, 5/14; 10118374, 6/14; 10122380, 9/14; 10122382, 10/14 and 10126771, 10/14. 5) PRIVATE LABEL Lot number and exp date: 10 ct blister pack: 10099646, 9/13; 10099649, 10/13; 10099650, 10/13; 10101298, 11/13; 10103516, 12/13; 10103517, 12/13; 10106238, 1/14; 10109434, 2/14; 10109863, 2/14; 10112221, 3/14; 10112223, 3/14; 10118377, 7/14 and 10122381, 9/14. 30 ct blister pack: 10098127, 9/13; 10099646, 9/13; 10099648, 10/13; 10099649, 10/13; 10099650, 10/13; 10101298, 11/13; 10103516, 12/13; 10106235, 12/13; 10107030, 2/14; 10109436, 2/14; 10109864, 2/14; 10111297, 3/14; 10112221, 3/14; 10114569, 4/14; 10114570, 4/14; 10114571, 4/14; 10116503, 5/14; 10116504, 5/14; 10116505, 5/14; 10118376, 7/14; 10118377, 7/14; 10118378, 7/14; 10122379, 8/14; 10122382, 10/14 and 10126770, 10/14. 6) WALMART BRAND, Equate, Allergy Relief, Loratadine Lot code and Exp date: 10 ct blister packs 10098127, 9/13; 10099648, 10/2013; 10099649, 10/13; 10101298, 11/13; 10101303, 11/13; 10103516, 12/13; 10106234, 12/13; 10106238, 1/14; 10107028, 1/14; 10109436, 2/14; 10109437, 2/14; 10109863, 2/14; 10109864, 2/14; 10111297, 3/14 and 10111298, 3/14. 30 ct blister pack 10098127, 9/13; 10099647, 9/13; 10099650, 10/13; 10101299, 11/13; 10103513, 11/13; 10103517, 12/13; 10106235, 12/13; 10107029, 1/14; 10107031, 2/14; 10109434, 2/14; 10109437, 2/14; 10109862, 2/14; 10111297, 3/14; 10111299, 3/14; 10111300, 3/14; 10112220, 3/14; 10112221, 3/14; 10114569, 4/14; 10116504, 5/14; 10116506, 6/14; 10118374, 6/14; 10118376, 7/31/2014 and 10118378, 7/14. 7) CVS Pharmacy, Allergy Relief Lot Code and Exp date: 5 ct blister pack 10101298, 11/13; 10106235, 12/13; 10109434, 2/14; 10109864, 2/14; 10112224, 4/14; 10114572, 4/14; 10116504, 5/14 and 10118374, 6/14. 10 ct blister packs: 10099646, 9/13; 10103516, 12/13; 10106238, 1/14; 10109434, 2/14; 10109863, 2/14; 10112221, 3/14 and 10118374, 6/14. 20 ct blister packs: 10099646, 9/13; 10099649, 10/13; 10103516, 12/13; 10106238, 1/14; 10107030, 2/14 and 10111297, 3/14. 10 + 10 ct blister pack: 10106234, 12/13. 30 ct blister packs: 10098127, 9/13; 10099646, 9/13; 10101298, 11/13; 10101302, 11/13; 10103517, 12/13; 10106235, 12/13; 10107028, 1/14; 10107031, 2/14; 10109864, 2/14; 10114573, 5/14 and 10118374, 6/14. 120 ct bottles: 10107028, 1/14 and 10109861, 2/14. 365 ct bottles: 10099647, 9/13; 10101297, 10/13; 10103515, 12/13; 10109860, 2/14; 10114569, 4/14; 10116505, 5/14 and 10122378, 8/14.
More code info
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