Reported Sep 28, 2022 · Terminated

Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD.…

Unichem Pharmaceuticals USA 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: UNICHEM PHARMACEUTICALS USA INC · 1 Tower Center Blvd Ste 2200 · East Brunswick, NJ · 08816-1145

Is this the product you have?

  • Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only
  • Manufactured byUNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511
  • India Manufactured forUNICHEM PHARMACEUTICALS (USA), INC. East Brunswick, NJ 08816. NDC# 29300-137-01
Lot codes and dates
    • Lot # GCLH22005
    • exp. date 02/29/2024
Amount recalled
18,960 bottles of 100

Where it was sold

  • Nationwide

Why it was recalled

Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride 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 Mar 2, 2023 · Data as of Sep 19, 5:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.