FDA-Drug2014-10-22Class II

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

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
55.8 Kg
Manufactured in
135 Cantiague Rock Rd, N/A, Westbury, NY, United States
Products
Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0023-2015

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief