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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66232

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 03, 2013
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Novartis Consumer Health

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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.

D-022-2014
Recall number
D-022-2014
Initiated
September 03, 2013
Classification
Class III
Status
Terminated
Recalling firm
Novartis Consumer Health
Quantity
11,846,608 blister packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

Nationwide

Field note

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