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
Reported: February 12, 2020 Initiated: January 29, 2020 #D-0829-2020
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- UNICHEM PHARMACEUTICALS USA INC
- Units Affected
- 19161600 units
- Distribution
- Distributed Nationwide in the US
- Location
- East Brunswick, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by UNICHEM PHARMACEUTICALS USA INC. Units affected: 19161600 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 12, 2020. Severity: Low. Recall number: D-0829-2020.
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