FDA-Drug2015-08-05Class II
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.
Mutual Pharmaceutical Company, Inc.
Hazard
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Sold states
Nartionwide
Affected count
a) 39,036 bottles and b) 2,082 bottles
Manufactured in
1100 Orthodox St, N/A, Philadelphia, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1281-2015Don't want to check this manually?
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