FDA-Drug2015-08-05Class II

Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01

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
20,892 bottles
Manufactured in
1100 Orthodox St, N/A, Philadelphia, PA, United States
Products
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1282-2015

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