Reported Feb 12, 2020 · Terminated
Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, 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 0.1mg, Rx Only, 100-count bottle
- 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 Numbers
GCLL18108GCLL18109GCLL18110 - EXP 10/31/2020GCLL19003 EXP 12/31/2020
- Lot Numbers
- Amount recalled
- 19161600 units
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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