Home / Recalls / Gyma Laboratories Of Amer,Inc / D-0023-2015

D-0023-2015 Class II Terminated

Recalled by Gyma Laboratories Of Amer,Inc — Westbury, NY

Recall Details

Product Type
Drugs
Report Date
October 22, 2014
Initiation Date
July 9, 2014
Termination Date
June 4, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
55.8 Kg

Product Description

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

Reason for Recall

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.

Distribution Pattern

Nationwide

Code Information

Lot Numbers: 166247, 166248, Exp 10/2016

Other recalls by Gyma Laboratories Of Amer,Inc

  • D-0022-2015 Class II — Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines (July 9, 2014)
  • D-0021-2015 Class II — Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicin (July 9, 2014)
  • D-0024-2015 Class II — Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Prepara (July 9, 2014)