FDA-Drug2015-08-05Class II
Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) 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) 96,640 bottles; b) 17,808 bottles
Manufactured in
1100 Orthodox St, N/A, Philadelphia, PA, United States
Products
Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1280-2015Don't want to check this manually?
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