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Class II: temporary or reversible health riskTerminated

The Harvard Drug Group Fexofenadine Hydrochloride Tablets Recall

Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Majo…

The Harvard Drug Group · Livonia, MI

Risk level
Class II
Reported by FDA
Dec 29, 2021
Recall ID
D-0289-2022
Check your lot numberHow we source this data

Summary

The Harvard Drug Group recalled Fexofenadine Hydrochloride Tablets starting Aug 3, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0289-2022 on Dec 29, 2021. Reason: Failed Impurities/Degradation Specifications. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications

Product description

Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40

Lot numbers, UPCs & expiration codes

Lot, expiry: Lot H00005, exp 01/2022; Lot H00006, exp 04/2022; Lot H00007, exp 07/2022

Where it was sold

Nationwide USA

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-0289-2022
Classification
Class II
Status
Terminated
Recall initiated
Aug 3, 2021
FDA report date
Dec 29, 2021
Quantity
2,239 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
The Harvard Drug Group

Original FDA data

Every field from FDA enforcement report D-0289-2022, exactly as published.

Show all FDA fields
City
Livonia
State
MI
Status
Terminated
Country
United States
Event ID
88811
Address
17187 N Laurel Park Dr Ste 300
Code information
Lot, expiry: Lot H00005, exp 01/2022; Lot H00006, exp 04/2022; Lot H00007, exp 07/2022
Postal code
48152-2600
Report date
Dec 29, 2021
Product type
Drugs
Recall number
D-0289-2022
Classification
Class II
Recalling firm
The Harvard Drug Group
Product quantity
2,239 bottles
Termination date
Jul 16, 2023
Reason for recall
Failed Impurities/Degradation Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40
Distribution pattern
Nationwide USA
Recall initiation date
Aug 3, 2021
Initial firm notification
Letter
Center classification date
Dec 21, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0289-2022, published Dec 29, 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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