FDA-Drug2022-09-28Class III

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

UNICHEM PHARMACEUTICALS USA INC
Hazard

Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,

Sold states
Distributed Nationwide in the USA
Affected count
18,960 bottles of 100
Manufactured in
1 Tower Center Blvd Ste 2200, N/A, East Brunswick, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1541-2022

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