Multi-event November 2021 FDA Recall Allergy And Congestion by Dr. Reddy's Laboratories, Inc.

This Multi-event Class III drug recall was initiated by Dr. Reddy's Laboratories, Inc. on November 12, 2021 for the product Allergy And Congestion. 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-0267-2022 TERMINATED D-0275-2022 TERMINATED D-0271-2022 TERMINATED D-0269-2022 TERMINATED D-0272-2022 TERMINATED D-0274-2022 TERMINATED D-0270-2022 TERMINATED D-0268-2022 TERMINATED D-0273-2022 TERMINATED

Recall Number: D-0267-2022

Reason for Recall
Failed dissolution specifications
Initiated
11-12-2021
Reported
12-15-2021
Quantity
4896 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89042
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.
N/A
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.
USA Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-23-2023
Product Description About Product Description
Full technical description of the product.
Allergy & 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.

Batch or Lot Expiration Information

Lot# : AC2103329E, Exp 1/2023

Affected Packages Involved in this Recall

11822-7388-5 Allergy And Congestion

Recall Number: D-0275-2022

Reason for Recall
Failed dissolution specifications
Initiated
11-12-2021
Reported
12-15-2021
Quantity
2,928 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89042
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.
N/A
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.
USA Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-23-2023
Product Description About Product Description
Full technical description of the product.
Fexofenadine 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.

Batch or Lot Expiration Information

Lot# : AC2103329A

Affected Packages Involved in this Recall

43598-823-14 Fexofenadine Hcl And Pseudoephedrine Hci
43598-823-31 Fexofenadine Hcl And Pseudoephedrine Hci
43598-823-35 Fexofenadine Hcl And Pseudoephedrine Hci

Recall Number: D-0271-2022

Reason for Recall
Failed dissolution specifications
Initiated
11-12-2021
Reported
12-15-2021
Quantity
2184 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89042
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.
N/A
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.
USA Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-23-2023
Product Description About Product Description
Full technical description of the product.
Antihistamine & 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.

Batch or Lot Expiration Information

Lot# : AC2103329D, Exp 1/2023

Recall Number: D-0269-2022

Reason for Recall
Failed dissolution specifications
Initiated
11-12-2021
Reported
12-15-2021
Quantity
5016 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89042
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.
N/A
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.
USA Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-23-2023
Product Description About Product Description
Full technical description of the product.
Fexofenadine 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.

Batch or Lot Expiration Information

Lot# : AC2103329F, Exp 1/2023

Affected Packages Involved in this Recall

43598-823-14 Fexofenadine Hcl And Pseudoephedrine Hci
43598-823-31 Fexofenadine Hcl And Pseudoephedrine Hci
43598-823-35 Fexofenadine Hcl And Pseudoephedrine Hci

Recall Number: D-0272-2022

Reason for Recall
Failed dissolution specifications
Initiated
11-12-2021
Reported
12-15-2021
Quantity
2496 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89042
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.
N/A
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.
USA Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-23-2023
Product Description About Product Description
Full technical description of the product.
12 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.

Batch or Lot Expiration Information

Lot# : AC2103329G, Exp 1/2023

Recall Number: D-0274-2022

Reason for Recall
Failed dissolution specifications
Initiated
11-12-2021
Reported
12-15-2021
Quantity
9,984 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89042
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.
N/A
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.
USA Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-23-2023
Product Description About Product Description
Full technical description of the product.
Allergy 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.

Batch or Lot Expiration Information

Lot# : AC2103329B

Recall Number: D-0270-2022

Reason for Recall
Failed dissolution specifications
Initiated
11-12-2021
Reported
12-15-2021
Quantity
2352 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89042
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.
N/A
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.
USA Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-23-2023
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

Lot# : AC2103329H, Exp 1/2023

Recall Number: D-0268-2022

Reason for Recall
Failed dissolution specifications
Initiated
11-12-2021
Reported
12-15-2021
Quantity
14976 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89042
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.
N/A
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.
USA Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-23-2023
Product Description About Product Description
Full technical description of the product.
Allergy & 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 69842-249-20

Batch or Lot Expiration Information

Lot# : AC2103329I, Exp 1/2023

Recall Number: D-0273-2022

Reason for Recall
Failed dissolution specifications
Initiated
11-12-2021
Reported
12-15-2021
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89042
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.
N/A
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.
USA Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-23-2023
Product Description About Product Description
Full technical description of the product.
Allergy 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 69842-249-30

Batch or Lot Expiration Information

Lot# : AC2103329C, Exp 1/2023