FDAClass IIJanuary 22, 2014

Glycerin-chromated recall: Sterility Concern

GLYCERIN-CHROMATED (W/V)* 72% INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Why was Glycerin-chromated recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 07082013@7, t07112013@1, 08022013@9, t08142013@35, t08222013@15, t10042013@2

Product
GLYCERIN-CHROMATED (W/V)* 72% INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Recalling firm
Specialty Medicine Compounding Pharmacy
Quantity
210 mL
Distribution
Hospitals, clinics, physicians, and patients in the Michigan area only.
Recall date
January 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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