FDAClass IINovember 5, 2014

PGE 3, 200 mcg/mL injectable recall: Sterility Concern

PGE 3, 200 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Why was PGE 3, 200 mcg/mL injectable recalled?

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to 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?

Lot Number: 08072014@40, Exp 11/5/2014

Product
PGE 3, 200 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Recalling firm
Martin Avenue Pharmacy, Inc.
Quantity
40 mL
Distribution
Nationwide
Recall date
November 5, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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