Recall Enforment Report D-0270-2022

Multi event Drug Recall Enforcement Report Class III done by Dr. Reddy's Laboratories, Inc., originally initiated on 11-12-2021 for the product Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0536-1242-34. The product was recalled due to failed dissolution specifications. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0270-202211-12-202112-15-2021Class III2352 cartonsAntihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0536-1242-34.Failed dissolution specificationsOngoing
D-0272-202211-12-202112-15-2021Class III2496 cartons12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Ohio 43107, Made in India, NDC 70000-0518-1.Failed dissolution specificationsOngoing
D-0271-202211-12-202112-15-2021Class III2184 cartonsAntihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0638-1242-07.Failed dissolution specificationsOngoing
D-0267-202211-12-202112-15-2021Class III4896 cartonsAllergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, 20 Extended-Release Tablets, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-7388-5.Failed dissolution specificationsOngoing
D-0268-202211-12-202112-15-2021Class III14976 cartonsAllergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets, 20 extended-release tablets, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, NDC 69842-249-20Failed dissolution specificationsOngoing
D-0275-202211-12-202112-15-2021Class III2,928 cartonsFexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ, 08640, Made in India NDC Walmart Inc., Bentonville, AR 72716, Product of India, NDC 43598-823-31.Failed dissolution specificationsOngoing
D-0269-202211-12-202112-15-2021Class III5016 cartonsFexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, NDC 43598-823-14.Failed dissolution specificationsOngoing
D-0273-202211-12-202112-15-2021Class IIIAllergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release Tablets USP, Distributed By CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02985, Made in India, NDC 69842-249-30Failed dissolution specificationsOngoing
D-0274-202211-12-202112-15-2021Class III9,984 cartonsAllergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Release Tablets USP, Distributed By Walmart Inc., Bentonville, AR 72716, Product of India, NDC 49035-273-30.Failed dissolution specificationsOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0536-1242Fexofenadine Hcl And Pseudoephedrine Hci Fexofenadine Hcl And Pseudoephedrine HciTablet, Extended ReleaseOralRugby LaboratoriesHuman Otc Drug
11822-7388Allergy And Congestion Fexofenadine Hcl And Pseudoephedrine HciTablet, Extended ReleaseOralRite Aid CorporationHuman Otc Drug
43598-823Fexofenadine Hcl And Pseudoephedrine Hci Fexofenadine Hcl And Pseudoephedrine HciTablet, Extended ReleaseOralDr. Reddy's Laboratories Inc.Human Otc Drug
49035-273Fexofenadine Hcl And Pseudoephedrine Hci Fexofenadine Hcl And Pseudoephedrine HciTablet, Extended ReleaseOralWal-mart Stores Inc.Human Otc Drug
69842-249Fexofenadine Hcl And Pseudoephedrine Hci Fexofenadine Hcl And Pseudoephedrine HciTablet, Extended ReleaseOralCvs PharmacyHuman Otc Drug
70000-051812hr Allergy And Congestion Relief Fexofenadine Hcl And Pseudoephedrine HciTablet, Extended ReleaseOralCardinal HealthHuman Otc Drug