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Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufactured by Novartis Co...

FDA Drug Recall #D-022-2014 — Class III — September 3, 2013

Recall Summary

Recall Number D-022-2014
Classification Class III — Low risk
Date Initiated September 3, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Novartis Consumer Health
Location Lincoln, NE
Product Type Drugs
Quantity 11,846,608 blister packs

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.

Reason for Recall

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

Distribution Pattern

Nationwide

Lot / 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.

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Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.

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