Allergy & Cold Medication Recalls

Recalls of antihistamines, decongestants and nasal sprays.

320 recalls in this category, newest first.

Class III · Low risk Terminated Jul 28, 2015

Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 49348-930-01 D-0037-2016

Class III · Low risk Terminated Jul 28, 2015

Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box, Distributed by Target Corp, Minneapolis…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 11673-527-31 D-0036-2016

Class III · Low risk Terminated Jul 28, 2015

Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 21130-527-69 D-0034-2016

Class III · Low risk Terminated Jul 28, 2015

Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 68016-527-31 D-0033-2016

Class III · Low risk Terminated Jul 28, 2015

Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 Livingston…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 51660-527-31 D-0032-2016

Class III · Low risk Terminated Jul 28, 2015

Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 0904-5806-15 D-0031-2016

Class III · Low risk Terminated Jul 28, 2015

Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 37205-745-65 D-0030-2016

Class III · Low risk Terminated Jul 28, 2015

HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. D-0029-2016

Class III · Low risk Terminated Jul 28, 2015

Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by: McKesson…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 62011-0073-1 D-0028-2016

Class III · Low risk Terminated Jul 28, 2015

Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 24385-0161-52 D-0027-2016

Class III · Low risk Terminated Jul 28, 2015

Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. D-0026-2016

Class III · Low risk Terminated Jul 28, 2015

Equaline Original Prescription Strength, loratadine orally disintegrating tablets, USP, 10 mg, packaged in a) 10-count tablets…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 41163-528-69 D-0025-2016

Class III · Low risk Terminated Jul 28, 2015

Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. D-0024-2016

Class III · Low risk Terminated Jul 28, 2015

CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. D-0023-2016

Class III · Low risk Terminated Jul 28, 2015

CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a)…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 41520-525-69 D-0022-2016

Class III · Low risk Terminated Jul 28, 2015

Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Proudly Distributed…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. D-0021-2016

Class III · Low risk Terminated Jul 28, 2015

Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. D-0020-2016

Class III · Low risk Terminated Jul 28, 2015

QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 63868-157-10 D-0019-2016

Class II · Moderate risk Terminated May 28, 2015

Diphenhydramine HCl, Diphenhydramine 25mg / NS 10 ml syringe, Qty: 2 10 mL syringes, Rx Only. Compounded by: United Medical IV…

Reason Lack of Assurance of Sterility: Sterility of product is not assured.

Lincare, Inc. D-1190-2015

Class III · Low risk Terminated May 4, 2015

Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. D-1142-2015

Class I · High risk Terminated Apr 15, 2015

Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Diphenhydramine HCl…

Reason Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the…

Reckitt Benckiser LLC NDC 63824-500-66 D-1364-2015

Class III · Low risk Terminated Apr 15, 2015

Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count…

Reason Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.

Sandoz, Inc NDC 66394-041-06 D-1115-2015

Class III · Low risk Terminated Mar 26, 2015

Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons…

Reason Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound…

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-547-20 D-1083-2015

Class III · Low risk Terminated Mar 11, 2015

Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription…

Reason Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.

Mylan Pharmaceuticals Inc. NDC 0378-0781-91 D-0435-2015

Class II · Moderate risk Terminated Mar 6, 2015

DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. Fusion Pharmaceuticals…

Reason Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.

Fusion Pharmaceuticals, LLC D-0410-2015

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