PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 9, 2013 Initiated: September 26, 2012 #D-116-2013

Product Description

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

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
20 vials
Distribution
Nationwide
Location
Framingham, MA

Frequently Asked Questions

What product was recalled?
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. Recalled by New England Compounding Center. Units affected: 20 vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on January 9, 2013. Severity: Moderate. Recall number: D-116-2013.