Mutual Pharmaceutical Company, Inc. recalls Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 53489-216-01) and b) 1000 count (NDC 53489-2
Recalled August 5, 2015 · FDA recall D-1281-2015 · Mutual Pharmaceutical
Hazard
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer · FDA Class II
Units
a) 39,036 bottles and b) 2,082 bottles
Sold at
Nartionwide
Description
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Product
Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 53489-216-01) and b) 1000 count (NDC 53489-216-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA.
Manufacturer(s)
Mutual Pharmaceutical Company, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →