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Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufact...

FDA Recall #D-116-2013 — Class II — September 26, 2012

Recall #D-116-2013 Date: September 26, 2012 Classification: Class II Status: Terminated

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

Recalling Firm

New England Compounding Center — Framingham, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

20 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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