September 2018 FDA Recall Clozapine by Teva Pharmaceuticals Usa
D-0001-2019 - Failed Disintegration Specifications
This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on September 21, 2018 for the product Clozapine. The FDA reported the reason for recall as failed disintegration specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0001-2019
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
09-21-2018
10-10-2018
313 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
Teva Pharmaceuticals USA
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.
Distributed nationwide in the USA
05-01-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.
Batch or Lot Expiration Information
Lot# : 34034024B, Exp 02/20
