Reported Aug 22, 2012 · Terminated

Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd by: Cadila Healthcare Ltd.,…

American Health Packaging

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: American Health Packaging · 2550 John Glenn Ave Ste A · Columbus, OH · 43217-1188

Is this the product you have?

  • Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only
  • Mfd byCadila Healthcare Ltd., Ahmedabad, India
  • Dist ByZydus Pharmaceuticals USA, Inc., Pennington, NJ 08534
  • Pkg by
    • American Health Packaging
    • Col. OH 43217
    • NDC 68084-343-21
    • blister barcode 6808434311
Lot codes and dates
    • Lot #: 113032A
    • 113032B
    • Exp 04/13
Amount recalled
1,170 cartons

Where it was sold

  • Nationwide

Why it was recalled

Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "Tablets".

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 Jul 2, 2013 · Data as of Sep 19, 5:47 PM UTC

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