FDAClass IIDecember 27, 2017

All Sterile Products within expiry recall: Sterility Concern

All Sterile Products within expiry

Why was All Sterile Products within expiry recalled?

Lack of Assurance of Sterility .

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?

Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products

Product
All Sterile Products within expiry
Recalling firm
Vital Rx, Inc. dba Atlantic Pharmacy and Compounding
Quantity
61 Products
Distribution
Nationwide.
Recall date
December 27, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls