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Class II: temporary or reversible health riskTerminated

Aurolife Pharma Wal-Fex Recall

Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed…

Aurolife Pharma, LLC · Dayton, NJ

Risk level
Class II
Reported by FDA
Sep 25, 2019
Recall ID
D-1873-2019
Check your lot numberHow we source this data

Summary

Aurolife Pharma recalled Wal-Fex starting Aug 23, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1873-2019 on Sep 25, 2019. Reason: Failed Impurities/Degradation Specifications. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications

Product description

Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0097-55.

Lot numbers, UPCs & expiration codes

Lot #: 06718027A1, Exp 09/21

Where it was sold

Nationwide in the 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-1873-2019
Classification
Class II
Status
Terminated
Recall initiated
Aug 23, 2019
FDA report date
Sep 25, 2019
Quantity
4920 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Aurolife Pharma, LLC

Original FDA data

Every field from FDA enforcement report D-1873-2019, exactly as published.

Show all FDA fields
City
Dayton
State
NJ
Status
Terminated
Country
United States
Event ID
83581
Address
2400 US Highway 130
Code information
Lot #: 06718027A1, Exp 09/21
Postal code
08810-1519
Report date
Sep 25, 2019
Product type
Drugs
Recall number
D-1873-2019
Classification
Class II
Recalling firm
Aurolife Pharma, LLC
Product quantity
4920 cartons
Termination date
Aug 16, 2022
Reason for recall
Failed Impurities/Degradation Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0097-55.
Distribution pattern
Nationwide in the USA
Recall initiation date
Aug 23, 2019
Initial firm notification
Letter
Center classification date
Sep 17, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1873-2019, published Sep 25, 2019. 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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