March 2019 FDA Recall Lansoprazole by Teva Pharmaceuticals Usa
D-1006-2019 - Subpotent Drug.
This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on March 11, 2019 for the product Lansoprazole. The FDA reported the reason for recall as subpotent drug.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1006-2019
Subpotent Drug.
03-11-2019
03-27-2019
7,081 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.
Nationwide in the United States.
11-15-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx only, Manufactured in Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0093-3008-93
Batch or Lot Expiration Information
Lot# : 25Q002, Exp. 11/2019
