Multi-event January 2022 FDA Recall Fexofenadine Hcl And Pseudoephedrine Hci by Dr. Reddy's Laboratories, Inc.

This Multi-event Class III drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on January 4, 2022 for the product Fexofenadine Hcl And Pseudoephedrine Hci. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0386-2022 TERMINATED D-0385-2022 TERMINATED D-0378-2022 TERMINATED D-0380-2022 TERMINATED D-0382-2022 TERMINATED D-0384-2022 TERMINATED D-0381-2022 TERMINATED D-0379-2022 TERMINATED D-0383-2022 TERMINATED

Recall Number: D-0386-2022

Reason for Recall
Failed Dissolution Specifications
Initiated
01-04-2022
Reported
01-26-2022
Quantity
10,536 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89364
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-20-2023
Product Description About Product Description
Full technical description of the product.
Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by Cardinal Health, Dublin, Ohio 43077, Made in India.

Batch or Lot Expiration Information

Lot# s: 79C002625B, Exp. 4/30/2022; AC2103328G, Exp. 1/31/2023; AC2106452C, Exp. 3/31/2023.

Recall Number: D-0385-2022

Reason for Recall
Failed Dissolution Specifications
Initiated
01-04-2022
Reported
01-26-2022
Quantity
41,784 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89364
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-20-2023
Product Description About Product Description
Full technical description of the product.
CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI, 02895, Made in India.

Batch or Lot Expiration Information

Lot# s: a) (20-count): AC2000968A; AC2000968F, Exp. 8/31/2022. b) (30-count): 79C002624B, Exp. 4/30/2022; AC2103330G; AC2103330H, Exp. 1/31/2023.

Recall Number: D-0378-2022

Reason for Recall
Failed Dissolution Specifications
Initiated
01-04-2022
Reported
01-26-2022
Quantity
67,848 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89364
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-20-2023
Product Description About Product Description
Full technical description of the product.
Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 0363-1606-20, b) 30 Extended Release Tablets per box, NDC 0363-1606-30, Distributed by: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015, Made in India.

Batch or Lot Expiration Information

Lot# s: a) (20-count box): AC2000968D, Exp. 8/31/2022; AC2103330J, Exp. 1/31/2023; AC2106452A; AC2106452H, Exp. 3/31/2023. b) (30-count box): 79C002624C, Exp. 4/30/2022; AC2103328B; AC2103328C; AC2103330A; AC2103330B, Exp. 1/31/2023.

Affected Packages Involved in this Recall

0363-1606-30 Fexofenadine Hcl And Pseudoephedrine Hci
0363-1606-20 Fexofenadine Hcl And Pseudoephedrine Hci

Recall Number: D-0380-2022

Reason for Recall
Failed Dissolution Specifications
Initiated
01-04-2022
Reported
01-26-2022
Quantity
7,080 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89364
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-20-2023
Product Description About Product Description
Full technical description of the product.
Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20 Extended-Release Tablets per box, UPC 011822738873, Distributed by Rite Aid, 30 United Lane, Camp Hill, PA 17011, Made in India.

Batch or Lot Expiration Information

Lot# : AC2103330D, Exp.1/31/2023; AC2106452E, Exp. 3/31/2023.

Recall Number: D-0382-2022

Reason for Recall
Failed Dissolution Specifications
Initiated
01-04-2022
Reported
01-26-2022
Quantity
9,912 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89364
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-20-2023
Product Description About Product Description
Full technical description of the product.
Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, UPC 343598823317, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Made in India.

Batch or Lot Expiration Information

Lot# s: a) (10-count): AC2103328D, Exp. 1/31/2023. b) (20-count) :AC2000968C, Exp. 8/31/2022. c) (30-count): AC2103330C, Exp. 1/31/2023; AC2106452D, Exp. 3/31/2023.

Recall Number: D-0384-2022

Reason for Recall
Failed Dissolution Specifications
Initiated
01-04-2022
Reported
01-26-2022
Quantity
9,984 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89364
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-20-2023
Product Description About Product Description
Full technical description of the product.
QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India.

Batch or Lot Expiration Information

Lot# s: 79C002624D; 79C002625C, Exp. 4/30/2022.

Recall Number: D-0381-2022

Reason for Recall
Failed Dissolution Specifications
Initiated
01-04-2022
Reported
01-26-2022
Quantity
11,064 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89364
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-20-2023
Product Description About Product Description
Full technical description of the product.
Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended-Release Tablets USP, 20 tablets per box, NDC 30142-611-14, Distributed by the Kroger Co., Cincinnati, Ohio, 45202, Made in India.

Batch or Lot Expiration Information

Lot# s: AC2000968E, Exp. 8/31/2022; AC2103328A; AC2103330I, Exp. 1/31/2023; AC2106452B, Exp. 3/31/2023.

Affected Packages Involved in this Recall

30142-611-14 Fexofenadine Hcl And Pseudoephedrine Hci

Recall Number: D-0379-2022

Reason for Recall
Failed Dissolution Specifications
Initiated
01-04-2022
Reported
01-26-2022
Quantity
2,352 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89364
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-20-2023
Product Description About Product Description
Full technical description of the product.
Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India.

Batch or Lot Expiration Information

Lot# : AC2106452F, Exp. 3/31/2023

Recall Number: D-0383-2022

Reason for Recall
Failed Dissolution Specifications
Initiated
01-04-2022
Reported
01-26-2022
Quantity
137,856 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89364
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-20-2023
Product Description About Product Description
Full technical description of the product.
equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 49035-273-20, b) 30 Extended Release Tablets per box, NDC 49035-273-30, Distributed by: Walmart Inc., Bentonville, AR 72716, Product of India.

Batch or Lot Expiration Information

Lot# s: a) (20-count): 79C002624A, Exp. 4/30/2022; AC2000968B, Exp. 8/31/2022; AC2103328F; AC2103330E, Exp.1/31/2023; AC2106452I, Exp. 3/31/2023. b) (30-count): 79C002625A, Exp. 4/30/2022; AC2103328E; AC2103330F, Exp. 1/31/2023; AC2106452G, Exp. 3/31/2023.