FDAFDA · Food and drugs·Recall number D-0829-2020
Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilerne Ind. Estate, Pilerne Bardez, Goa 403 511 India. Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816. NDC 29300-135-01
Published February 12, 2020 · Recall initiated: January 29, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CLONIDINE HYDROCHLORIDE
- Manufacturer
- UNICHEM PHARMACEUTICALS USA INC
- Distributor
- Distributed Nationwide in the US
- UPC
- 0329300137019
- Lot
- Lot Numbers: GCLL18108, GCLL18109, GCLL18110 - EXP 10/31/2020; GCLL19003 EXP 12/31/2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.