Recalls / Class III
Class IIID-1291-2020
Product
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
- 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 #: GCLL19034, GCLL19035, GCLL19036, Exp. 4/30/2021; GCLL19044, Exp. 6/30/2021
Why it was recalled
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
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
- 190,992 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-05-26
- FDA classified
- 2020-06-08
- Posted by FDA
- 2020-06-17
- Terminated
- 2021-01-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1291-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.