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Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Lab...

FDA Recall #D-1427-2012 — Class III — July 23, 2012

Recall #D-1427-2012 Date: July 23, 2012 Classification: Class III Status: Terminated

Product Description

Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90.

Reason for Recall

Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.

Recalling Firm

Stat Rx USA — Gainesville, GA

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

51 Bottles

Distribution

Nationwide

Code Information

Lot #: 28JN1272, Exp 02/15

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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