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Allergy & Cold Medication Recalls

Recalls of antihistamines, decongestants and nasal sprays.

320 recalls in this category, newest first.

Class II · Moderate risk Ongoing Jun 23, 2022

QP DPHNHDRME ALRGY MIN TBLT 12 CT SKU 900449 QP ALLERGY DIPHENHYDRAMINE 25 MG 48 CT SKU 916003 QP ALLERGY MULTI SYMPTOM CAPLET…

Reason CGMP Deviations: product held outside appropriate storage temperature conditions.

Family Dollar Stores, Llc. D-1450-2022

Class II · Moderate risk Terminated Jun 13, 2022

Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH…

Reason Defective container: defect prevents product from dispensing as intended.

Akorn, Inc. NDC 50383-700-16 D-1172-2022

Class II · Moderate risk Terminated Jun 7, 2022

CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual…

Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Plastikon Healthcare LLC NDC 62320-302-05 D-1492-2022

Class II · Moderate risk Terminated Jun 7, 2022

Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional…

Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Plastikon Healthcare LLC NDC 0904-6741-72 D-1489-2022

Class II · Moderate risk Terminated Jun 7, 2022

Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional…

Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Plastikon Healthcare LLC NDC 0904-6740-70 D-1488-2022

Class II · Moderate risk Terminated Apr 13, 2022

Diphenhydramine HCl oral solution, USP, 25 mg/10 mL UD, packaged in a) 10 mL unit dose cups (NDC 0121-0978-10), b) 100-count box…

Reason cGMP deviations: Temperature abuse

Mckesson Medical-Surgical Inc. Corporate Office NDC 0121-0978-10 D-1101-2022

Class II · Moderate risk Terminated Jan 26, 2022

Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC…

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-785-00 D-0552-2022

Class II · Moderate risk Terminated Jan 26, 2022

Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder…

Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Cardinal Healthcare D-0202-2024

Class II · Moderate risk Terminated Jan 26, 2022

Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx…

Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Cardinal Healthcare D-0182-2024

Class II · Moderate risk Terminated Jan 24, 2022

Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufactured for…

Reason cGMP deviations

Ultra Seal Corporation NDC 10237-907-50 D-0470-2022

Class III · Low risk Terminated Jan 10, 2022

Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36-count blister pack packed into cartons…

Reason Subpotent drug

Dr. Reddy's Laboratories, Inc. NDC 0363-164-3 D-0388-2022

Class III · Low risk Terminated Jan 4, 2022

Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20…

Reason Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. NDC 70000-0518-1 D-0386-2022

Class III · Low risk Terminated Jan 4, 2022

CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended…

Reason Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. D-0385-2022

Class III · Low risk Terminated Jan 4, 2022

QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10…

Reason Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. NDC 63868-729-10 D-0384-2022

Class III · Low risk Terminated Jan 4, 2022

equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Release…

Reason Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. NDC 49035-273-20 D-0383-2022

Class III · Low risk Terminated Jan 4, 2022

Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC…

Reason Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. D-0382-2022

Class III · Low risk Terminated Jan 4, 2022

Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended-Release…

Reason Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. NDC 30142-611-14 D-0381-2022

Class III · Low risk Terminated Jan 4, 2022

Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20…

Reason Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. D-0380-2022

Class III · Low risk Terminated Jan 4, 2022

Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP…

Reason Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. NDC 0536-1242-07 D-0379-2022

Class III · Low risk Terminated Jan 4, 2022

Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a)…

Reason Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. NDC 0363-1606-20 D-0378-2022

Class III · Low risk Terminated Nov 12, 2021

Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets…

Reason Failed dissolution specifications

Dr. Reddy's Laboratories, Inc. NDC 43598-823-31 D-0275-2022

Class III · Low risk Terminated Nov 12, 2021

Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Release…

Reason Failed dissolution specifications

Dr. Reddy's Laboratories, Inc. NDC 49035-273-30 D-0274-2022

Class III · Low risk Terminated Nov 12, 2021

Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release Tablets…

Reason Failed dissolution specifications

Dr. Reddy's Laboratories, Inc. NDC 69842-249-30 D-0273-2022

Class III · Low risk Terminated Nov 12, 2021

12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20…

Reason Failed dissolution specifications

Dr. Reddy's Laboratories, Inc. NDC 70000-0518-1 D-0272-2022

Class III · Low risk Terminated Nov 12, 2021

Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy…

Reason Failed dissolution specifications

Dr. Reddy's Laboratories, Inc. NDC 0638-1242-07 D-0271-2022