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SODIUM HYDROXIDE (BAC.STATIC) 10% SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350...

FDA Recall #D-460-2014 — Class II — October 19, 2013

Recall #D-460-2014 Date: October 19, 2013 Classification: Class II Status: Terminated

Product Description

SODIUM HYDROXIDE (BAC.STATIC) 10% SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Reason for Recall

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Recalling Firm

Specialty Medicine Compounding Pharmacy — South Lyon, MI

Classification

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

Product Type

Drugs

Product Quantity

10 mL

Distribution

Hospitals, clinics, physicians, and patients in the Michigan area only.

Code Information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10152013@20

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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