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Prednisolone Anhydrous Micronized active pharmaceutical ingredient packaged in varying grams or k...

FDA Recall #D-857-2015 — Class II — November 14, 2014

Recall #D-857-2015 Date: November 14, 2014 Classification: Class II Status: Terminated

Product Description

Prednisolone Anhydrous Micronized active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada

Reason for Recall

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Recalling Firm

Attix Pharmaceuticals — Toronto

Classification

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

Product Type

Drugs

Product Quantity

200 grams

Distribution

Nationwide to compounding pharmacies and research organizations.

Code Information

All lots repackaged and distributed between 01/05/12 to 02/12/15

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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