D-66373-001 Class III Terminated

Recalled by Sandoz Incorporated — Broomfield, CO

FDA drug recall D-66373-001 was initiated by Sandoz Incorporated on September 25, 2013 and is designated Class III. Reason for recall: Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets. The recall status is terminated (terminated July 16, 2014). Affected quantity: 25,830 bottles.

Recall Details

Product Type
Drugs
Report Date
October 16, 2013
Initiation Date
September 25, 2013
Termination Date
July 16, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
25,830 bottles

Product Description

Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., Princeton NJ, 08540, NDC 0781-1407-01.

Reason for Recall

Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.

Distribution Pattern

Nationwide

Code Information

Lot #: BU3417, Exp 06/2014