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Class II: temporary or reversible health riskTerminated

Qualitest Pharmaceuticals Glimepiride Tablets Recall

GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for:…

Qualitest Pharmaceuticals · Huntsville, AL

Risk level
Class II
Reported by FDA
May 1, 2013
Recall ID
D-298-2013
Check your lot numberHow we source this data

Summary

Qualitest Pharmaceuticals recalled Glimepiride Tablets starting Apr 19, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-298-2013 on May 1, 2013. Reason: Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level. Status: Terminated.

Why it was recalled

Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.

Product description

GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21.

Lot numbers, UPCs & expiration codes

Lot #: C0671212A, Exp 12/14

Where it was sold

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-298-2013
Classification
Class II
Status
Terminated
Recall initiated
Apr 19, 2013
FDA report date
May 1, 2013
Quantity
10,373 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Qualitest Pharmaceuticals

Original FDA data

Every field from FDA enforcement report D-298-2013, exactly as published.

Show all FDA fields
City
Huntsville
State
AL
Status
Terminated
Country
United States
Event ID
64960
Address
120 Vintage Dr NE
Code information
Lot #: C0671212A, Exp 12/14
Postal code
35811-8216
Report date
May 1, 2013
Product type
Drugs
Recall number
D-298-2013
Classification
Class II
Recalling firm
Qualitest Pharmaceuticals
Product quantity
10,373 bottles
Termination date
Jan 13, 2014
Reason for recall
Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.
Voluntary / mandated
Voluntary: Firm initiated
Product description
GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21.
Distribution pattern
Nationwide
Recall initiation date
Apr 19, 2013
Initial firm notification
Letter
Center classification date
Apr 25, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-298-2013, published May 1, 2013. 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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