Reported Jun 17, 2020 · Terminated
Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, 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 0.1 mg 100-count bottles, 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 29300-135-01
- Lot codes and dates
Lot #: GCLL19034GCLL19035GCLL19036Exp. 4/30/2021GCLL19044Exp. 6/30/2021
- Amount recalled
- 190,992 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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