FDAClass IDecember 31, 2014

Glutathione 100mg/mL Sterile Injection recall: Sterility Concern

Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.

Why was Glutathione 100mg/mL Sterile Injection recalled?

Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.

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?

Lot #: 05122014@4, Exp 09/09/2014

Product
Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
Recalling firm
Pharmacy Creations
Quantity
12 vials
Distribution
Directly to patients and physicians in FL, NJ, NY, and Puerto Rico
Recall date
December 31, 2014
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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