drugs Class II Updated 2014-10-22

Gyma Laboratories Of Amer,Inc recalls Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chem

Recalled Product

Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01

Hazard / Issue

cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 166247, 166248, Exp 10/2016
View official government recall

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