Recalls / Class III
Class IIID-0829-2020
Product
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
- Brand name
- Clonidine Hydrochloride
- Generic name
- Clonidine Hydrochloride
- Active ingredient
- Clonidine Hydrochloride
- Route
- Oral
- NDCs
- 29300-136, 29300-468, 29300-137, 29300-135
- FDA application
- ANDA078895
- Affected lot / code info
- Lot Numbers: GCLL18108, GCLL18109, GCLL18110 - EXP 10/31/2020; GCLL19003 EXP 12/31/2020
Why it was 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.
Recalling firm
- Firm
- UNICHEM PHARMACEUTICALS USA INC
- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Tower Center Blvd Ste 2200, N/A, East Brunswick, New Jersey 08816-1145
Distribution
- Quantity
- 19161600 units
- Distribution pattern
- Distributed Nationwide in the US
Timeline
- Recall initiated
- 2020-01-29
- FDA classified
- 2020-02-06
- Posted by FDA
- 2020-02-12
- Terminated
- 2021-01-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0829-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.