Reason Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the…
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)NDC 51079-182-20D-0377-2015
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Reason Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients…
Reason Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients…
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…
Reason Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril…
Dr. Reddy's Laboratories, Inc.NDC 55111-127-05D-1435-2012