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Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manu...

FDA Recall #D-111-2013 — Class I — September 26, 2012

Recall #D-111-2013 Date: September 26, 2012 Classification: Class I Status: Terminated

Product Description

Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

Reason for Recall

Non-Sterility

Recalling Firm

New England Compounding Center — Framingham, MA

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

3822 vials

Distribution

Nationwide

Code Information

All lot codes

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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