Recalls / Class III
Class IIID-1541-2022
Product
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, 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# 29300-137-01
- 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 # GCLH22005, exp. date 02/29/2024
Why it was recalled
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
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
- 18,960 bottles of 100
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2022-09-19
- FDA classified
- 2022-09-22
- Posted by FDA
- 2022-09-28
- Terminated
- 2023-03-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1541-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.