FDAFDA · Food and drugs·Recall number D-1291-2020
Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, 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 June 17, 2020 · Recall initiated: May 26, 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/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CLONIDINE HYDROCHLORIDE
- Manufacturer
- UNICHEM PHARMACEUTICALS USA INC
- Distributor
- Nationwide within the United States
- UPC
- 0329300137019
- Lot
- Lot #: GCLL19034, GCLL19035, GCLL19036, Exp. 4/30/2021; GCLL19044, Exp. 6/30/2021
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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