Unichem Recalls Clonidine Hydrochloride Tablets Due to Benzophenone Migration
Unichem Pharmaceuticals is recalling Clonidine Hydrochloride tablets due to potential benzophenone migration from container labels. This is a precautionary measure.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The source describes the issue as a precautionary measure involving very low levels of migration.
Plain-English summary
Unichem Pharmaceuticals USA Inc is recalling specific lots of Clonidine Hydrochloride Tablets, USP 0.1mg. The recall is initiated as a precautionary measure due to the potential migration of benzophenone at very low levels into the product from the container label.
The affected product is a prescription-only medication manufactured by Unichem Laboratories Ltd in India for Unichem Pharmaceuticals (USA), Inc. The recall covers 19,161,600 units distributed nationwide in the US. Specific lot numbers include GCLL18108, GCLL18109, GCLL18110 (expiring 10/31/2020) and GCLL19003 (expiring 12/31/2020).
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. The FDA has classified this as a Class III recall, indicating that the violation is not likely to cause adverse health consequences.
The recalled product
- Product
- CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE)
- Brand
- CLONIDINE HYDROCHLORIDE
- Manufacturer
- UNICHEM PHARMACEUTICALS USA INC
- Category
- Drug — Prescription Tablets
- Affected units
- 19,161,600
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Numbers: GCLL18108
- GCLL18109
- GCLL18110 - EXP 10/31/2020
- GCLL19003 EXP 12/31/2020
UPCs (4)
- 0329300137019
- 0329300136012
- 0329300135015
- 0329300468014
Distribution
Distributed nationwide across the United States.
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