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FDAJuly 9, 2015drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer

What to do

FDA enforcement status: Terminated

Brands named

mutual pharmaceuticalmutual

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear