FDA Recall D-109-2013
New England Compounding Center · Framingham, MA
Class I — life-threatening Terminated 1472 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
Reason for recall
Non-Sterility
Recall record
- Recall number
D-109-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide
- Recall initiated
- 2012-09-26
- Classified by FDA Center
- 2012-12-31
- FDA published
- 2013-01-09
- Terminated
- 2016-10-07
- Recalling firm
- New England Compounding Center
- Firm location
- Framingham, MA