FDA-Drug2014-10-22Class II

Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002

Gyma Laboratories Of Amer,Inc
Hazard

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.

Sold states
Nationwide
Affected count
97 Kg
Manufactured in
135 Cantiague Rock Rd, N/A, Westbury, NY, United States
Products
Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0024-2015

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