FDA Drug Recalls

Recalls / Class II

Class IID-053-2013

Product

All Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com

Affected lot / code info
All lot codes

Why it was recalled

GMP Deviations

Recalling firm

Firm
New England Compounding Center
Notification channel
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type
Voluntary: Firm initiated
Address
697 Waverly St, Framingham, Massachusetts 01702-8589

Distribution

Distribution pattern
Nationwide Japan

Timeline

Recall initiated
2012-10-06
FDA classified
2012-11-14
Posted by FDA
2012-11-21
Terminated
2016-10-07
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-053-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.