Reported Dec 13, 2017 · Terminated

Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ…

Elite Laboratories Inc.

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: Elite Laboratories Inc. · 165 Ludlow Ave · Northvale, NJ · 07647-2305

Is this the product you have?

    • Isradapine Capsules USP 2.5 mg
    • 100-count bottles
    • Rx only
  • Manufactured by
    • Elite Laboratories
    • Inc. Northvale
    • NJ 07647
    • NDC 42806-263-01
    • UPC 342806263013
Lot codes and dates
    • Lot #: P0910-017
    • Exp. 05/2019
Amount recalled
1264 bottles

Where it was sold

Why it was recalled

Failed Impurities/Degradation Specifications

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 Mar 15, 2019 · Data as of Sep 19, 6:29 PM UTC

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