From labels saying “you can take 4 pills” when it should really say “take 2” to injections with loose metal ferrules, here are last week’s recalls:

An FDA update a day keeps the recalls away.
Get free recall, 483, & Warning Letter reports.

DRUG RECALLS:

[supsystic-tables id=28]

UNCLASSIFIED RECALLS:

[supsystic-tables id=29]

Like this & want more?
Sign up to get free weekly content updates
designed to make your job easier.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at [email protected].

About the Author

Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence.  She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry.  At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers.  She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc.  This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends.  This was an essential service and tool within the Corporate Audit function.

Unger Consulting Inc. | www.ungerconsulting.net | 805.217.9360