D-1006-2019 Class III Terminated

Recalled by Teva Pharmaceuticals USA — North Wales, PA

FDA drug recall D-1006-2019 was initiated by Teva Pharmaceuticals USA on March 11, 2019 and is designated Class III. Reason for recall: Subpotent Drug. The recall status is terminated (terminated November 15, 2019). Affected quantity: 7,081 bottles.

Recall Details

Product Type
Drugs
Report Date
March 27, 2019
Initiation Date
March 11, 2019
Termination Date
November 15, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7,081 bottles

Product Description

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

Reason for Recall

Subpotent Drug.

Distribution Pattern

Nationwide in the United States.

Code Information

Lot #: 25Q002, Exp. 11/2019