Reported Aug 1, 2012 · Terminated

Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN…

Stat Rx USA

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stat Rx USA · 2481 Hilton Dr · Gainesville, GA · 30501-6213

Is this the product you have?

  • Tizanidine (Generic forZanaflex), 4 mg, 90 Tablets per Bottle, Rx only
  • Mfg ByDr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90
Lot codes and dates
    • Lot #: 28JN1272
    • Exp 02/15
Amount recalled
51 Bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 31, 2013 · Data as of Sep 19, 7:13 PM UTC

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