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Class III: unlikely to cause harmTerminated

Dr. Reddy's Laboratories Fexofenadine HCl 60 mg/ Pseudoephedrine HCl Recall

Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy…

Dr. Reddy's Laboratories, Inc. · Princeton, NJ

Risk level
Class III
Reported by FDA
Dec 15, 2021
Recall ID
D-0269-2022
Check your lot numberHow we source this data

Summary

Dr. Reddy's Laboratories recalled Fexofenadine HCl 60 mg/ Pseudoephedrine HCl starting Nov 12, 2021. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0269-2022 on Dec 15, 2021. Reason: Failed dissolution specifications. Status: Terminated.

Why it was recalled

Failed dissolution specifications

Product description

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.

Lot numbers, UPCs & expiration codes

Lot #: AC2103329F, Exp 1/2023

Where it was sold

USA Nationwide.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0269-2022
Classification
Class III
Status
Terminated
Recall initiated
Nov 12, 2021
FDA report date
Dec 15, 2021
Quantity
5016 cartons
Recall type
N/A
Recalling firm
Dr. Reddy's Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-0269-2022, exactly as published.

Show all FDA fields
City
Princeton
State
NJ
Status
Terminated
Country
United States
Event ID
89042
Address
107 College Rd E
Code information
Lot #: AC2103329F, Exp 1/2023
Postal code
08540-6623
Report date
Dec 15, 2021
Product type
Drugs
Recall number
D-0269-2022
Classification
Class III
Recalling firm
Dr. Reddy's Laboratories, Inc.
Product quantity
5016 cartons
Termination date
Jun 23, 2023
Reason for recall
Failed dissolution specifications
Product description
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.
Distribution pattern
USA Nationwide.
Recall initiation date
Nov 12, 2021
Initial firm notification
Letter
Center classification date
Dec 7, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0269-2022, published Dec 15, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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