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Recall Observatory FDA recall evidence

Drug product

Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

D-110-2013

September 26, 2012

Class I

Product summary

Firm
New England Compounding Center
Event
Event 63305
Status
Terminated
Classification
Class I
Quantity
5130 vials
Official record key
drug-enforcement:D-110-2013

Official wording

Reason: Non-Sterility

Code information: All lot codes

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-Sterility