September 2019 FDA Recall Matzim La by Teva Pharmaceuticals Usa
D-0131-2020 - GMP Deviation
This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on September 6, 2019 for the product Matzim La. The FDA reported the reason for recall as gmp deviation. The product was distributed in Product was distributed to 42 wholesalers and 11 retailers who may have further distribute the product throughout the United States, including Hawaii and Puerto Rico. and the recall is currently terminated.
Recall Number: D-0131-2020
GMP Deviation: lot not intended for commercial distribution.
09-06-2019
10-16-2019
5,849 bottles
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.
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.
Product was distributed to 42 wholesalers and 11 retailers who may have further distribute the product throughout the United States, including Hawaii and Puerto Rico.
05-19-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis Laboratories FL, Inc., Fort Lauderdale, FL, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 52544-692-30
Batch or Lot Expiration Information
Lot# 1344864A, exp. date 10/2020
