Recalls / Class II
Class IID-116-2013
Product
Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA
- Affected lot / code info
- All lot codes
Why it was recalled
Lack of Assurance of Sterility
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, N/A, Framingham, Massachusetts 01702-8589
Distribution
- Quantity
- 20 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-09-26
- FDA classified
- 2012-12-31
- Posted by FDA
- 2013-01-09
- Terminated
- 2016-10-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-116-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.