FDAClass IIAugust 15, 2018

Ascorbic Acid 500 mg/mL recall: Sterility Concern

Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Why was Ascorbic Acid 500 mg/mL recalled?

Lack of sterility assurance.

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?

Lots: 58555:42, 58567:42, 58563:42, 58547:42, 58565:42, Use By: 05/25/2018

Product
Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Recalling firm
Guardian Pharmacy Services
Quantity
5000 500-ml bags
Distribution
Texas
Recall date
August 15, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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