Allopurinol Tablet
FDA Recall NDC 0603-2115
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Allopurinol (NDC 0603-2115). A significant event, classified as Class III, was initiated on Jul 20, 2015 by Par Health Usa, Llc. The reported reason for this action was: "Failed Tablet/Capsule Specifications; report of oversized and discolored tablets"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
July 2015 Class III Recall: Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
Recall Number
Class III Terminated
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
Jul 20, 2015
Sep 09, 2015
21552 units
Recall Profile & Regulatory Data
Event ID
71776
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Qualitest Pharmaceuticals
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and PR
Termination Date
Mar 07, 2016
Product Description
ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 --- NDC 0603-2116-28
Batch or Lot Expiration Information
Lot# CP0761501, Exp. 12/16
Affected Packages Involved in this Recall
0603-2115-93Product
0603-2115-21Product
0603-2115-28Product
0603-2115-32Product
0603-2115-02Product
0603-2115-04Product
0603-2116-02Product
0603-2116-21Product
0603-2116-28Product
0603-2116-32Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
