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Recall Observatory FDA recall evidence

Drug product

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

D-66373-001

September 25, 2013

Class III

Product summary

Firm
Sandoz Incorporated
Event
Event 66373
Status
Terminated
Classification
Class III
Quantity
25,830 bottles
Official record key
drug-enforcement:D-66373-001

Official wording

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

Code information: Lot #: BU3417, Exp 06/2014

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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