July 2015 FDA Recall Allopurinol by Qualitest Pharmaceuticals
D-1405-2015 - Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
This Class III drug recall was voluntarily initiated by Qualitest Pharmaceuticals on July 20, 2015 for the product Allopurinol. The FDA reported the reason for recall as failed tablet/capsule specifications; report of oversized and discolored tablets. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1405-2015
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
07-20-2015
09-09-2015
21552 units
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Qualitest Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and PR
03-07-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
