Allergy & Cold Medication Recalls

Recalls of antihistamines, decongestants and nasal sprays.

320 recalls in this category, newest first.

Class II · Moderate risk Terminated Mar 15, 2021

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML 473ML; NDC/UPC…

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. D-0474-2021

Class II · Moderate risk Terminated Mar 15, 2021

Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-mg doses of naloxone HCl in 0.1 mL of nasal spray…

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 69547-353-02 D-0473-2021

Class I · High risk Ongoing Dec 17, 2020

ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (40mL) bottle, 270 measured sprays, Distributed by…

Reason Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast

NDAL Mfg Inc. D-0269-2021

Class III · Low risk Terminated Nov 11, 2020

Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New…

Reason Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.

InvaTech Pharma Solutions, LLC NDC 10135-0639-30 D-0115-2021

Class I · High risk Terminated Jul 21, 2020

STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap, Rx only, Manufactured for: CSL Behring…

Reason Superpotent Drug

Ferring Pharmaceuticals Inc NDC 0053-6871-00 D-1506-2020

Class I · High risk Terminated Jul 21, 2020

Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap, Rx only, Manufactured for: AMRING PHARMACEUTICALS…

Reason Superpotent Drug

Ferring Pharmaceuticals Inc NDC 69918-501-05 D-1505-2020

Class I · High risk Terminated Jul 21, 2020

DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring Pharmaceuticals Inc., Parsippany…

Reason Superpotent Drug

Ferring Pharmaceuticals Inc NDC 55566-2500-0 D-1504-2020

Class III · Low risk Terminated Feb 14, 2020

Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine, Indoor/Outdoor Allergies, 24 Hour…

Reason Labeling: Incorrect or Missing Lot and/or Expiration date.

AAA Pharmaceutical, Inc. NDC 53943-192-04 D-0868-2020

Class II · Moderate risk Terminated Aug 29, 2019

Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA…

Reason Failed Impurities/Degradation Specifications

Preferred Pharmaceuticals, Inc D-1877-2019

Class II · Moderate risk Terminated Aug 28, 2019

AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.

Reason Failed Stability Specifications.

AVKARE Inc. NDC 42291-297-50 D-1875-2019

Class II · Moderate risk Terminated Aug 23, 2019

Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by…

Reason Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC NDC 53943-021-09 D-1874-2019

Class II · Moderate risk Terminated Aug 23, 2019

Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed By: Walgreen Co., 200 Wilmot Rd…

Reason Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC NDC 0363-0097-55 D-1873-2019

Class II · Moderate risk Terminated Aug 23, 2019

Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed by: Aurohealth LLC, 2572 Brunswick Pike…

Reason Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC NDC 58602-820-09 D-1872-2019

Class II · Moderate risk Terminated Aug 23, 2019

Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville…

Reason Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC D-1871-2019

Class II · Moderate risk Terminated Aug 23, 2019

Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1); and b) 30-count cartons (NDC…

Reason Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC NDC 62011-0315-1 D-1870-2019

Class II · Moderate risk Terminated Aug 23, 2019

Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: Wal-Mart Stores, Inc…

Reason Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC NDC 49035-995-62 D-1869-2019

Class II · Moderate risk Terminated Aug 23, 2019

Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC…

Reason Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC NDC 70677-0008-2 D-1868-2019

Class II · Moderate risk Terminated Aug 23, 2019

fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bentonville…

Reason Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC NDC 68196-976-91 D-1867-2019

Class II · Moderate risk Terminated Aug 23, 2019

Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good Neighbor Pharmacy, Distributed By Amerisource…

Reason Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC NDC 46122-387-23 D-1866-2019

Class II · Moderate risk Terminated Aug 23, 2019

Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53); b) 30-count…

Reason Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC NDC 60000-409-53 D-1865-2019

Class II · Moderate risk Terminated Aug 23, 2019

Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike…

Reason Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC NDC 58602-711-21 D-1864-2019

Class II · Moderate risk Terminated Jul 15, 2019

DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured Single-Use…

Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

Unipharma, Llc. D-1632-2019

Class II · Moderate risk Terminated Jul 15, 2019

CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mixed Berry…

Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

Unipharma, Llc. NDC 69842-261-01 D-1631-2019

Class II · Moderate risk Terminated Jul 10, 2019

Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by…

Reason Microbial contamination of non-sterile product

LNK International, Inc. NDC 49035-330-02 D-1630-2019

Class II · Moderate risk Terminated Jun 24, 2019

Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC…

Reason Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R…

H J Harkins Company Inc dba Pharma Pac NDC 52959-0123-03 D-1430-2019

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