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Recall Observatory FDA recall evidence

Drug product

Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA

D-108-2013

September 26, 2012

Class I

Product summary

Firm
New England Compounding Center
Event
Event 63305
Status
Terminated
Classification
Class I
Quantity
23,897 vials
Official record key
drug-enforcement:D-108-2013

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