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Class II: temporary or reversible health riskTerminated

Aurolife Pharma Allergy Recall

Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT dr…

Aurolife Pharma, LLC · Dayton, NJ

Risk level
Class II
Reported by FDA
Sep 25, 2019
Recall ID
D-1874-2019
Check your lot numberHow we source this data

Summary

Aurolife Pharma recalled Allergy starting Aug 23, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1874-2019 on Sep 25, 2019. Reason: Failed Impurities/Degradation Specifications. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications

Product description

Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, NDC 53943-021-09.

Lot numbers, UPCs & expiration codes

Lot #: 067180024B1, Exp 07/21

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-1874-2019
Classification
Class II
Status
Terminated
Recall initiated
Aug 23, 2019
FDA report date
Sep 25, 2019
Quantity
4536 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Aurolife Pharma, LLC

Original FDA data

Every field from FDA enforcement report D-1874-2019, 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 #: 067180024B1, Exp 07/21
Postal code
08810-1519
Report date
Sep 25, 2019
Product type
Drugs
Recall number
D-1874-2019
Classification
Class II
Recalling firm
Aurolife Pharma, LLC
Product quantity
4536 cartons
Termination date
Aug 16, 2022
Reason for recall
Failed Impurities/Degradation Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, NDC 53943-021-09.
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-1874-2019, 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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