May 2022 FDA Recall Drug by Teva Pharmaceuticals Usa Inc
D-0992-2022 - Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.

This Class I drug recall was voluntarily initiated by Teva Pharmaceuticals Usa Inc on May 11, 2022 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications- low out-of-specification results obtained during stability testing.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0992-2022

Reason for Recall
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Initiated
05-11-2022
Reported
06-08-2022
Quantity
4224 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90182
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-26-2024
Product Description About Product Description
Full technical description of the product.
Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.

Batch or Lot Expiration Information

Lot# GD01090, Exp 05/2022