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
Reported: June 17, 2020 Initiated: May 26, 2020 #D-1291-2020
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Details
- Recalling Firm
- UNICHEM PHARMACEUTICALS USA INC
- Units Affected
- 190,992 bottles
- Distribution
- Nationwide within the United States
- Location
- East Brunswick, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by UNICHEM PHARMACEUTICALS USA INC. Units affected: 190,992 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 17, 2020. Severity: Low. Recall number: D-1291-2020.
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