D-0830-2020 Class II Terminated

Recalled by Teva Pharmaceuticals USA — Parsippany, NJ

FDA drug recall D-0830-2020 was initiated by Teva Pharmaceuticals USA on January 27, 2020 and is designated Class II. Reason for recall: GMP Deviations: Product bottle may be absent of desiccant. The recall status is terminated (terminated December 10, 2020). Affected quantity: 22,868 bottles.

Recall Details

Product Type
Drugs
Report Date
February 12, 2020
Initiation Date
January 27, 2020
Termination Date
December 10, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22,868 bottles

Product Description

Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2464-01

Reason for Recall

GMP Deviations: Product bottle may be absent of desiccant.

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 1281203M, exp. date 03/2020 and 1290113M, exp. date 04/2020