FDAClass IIAugust 4, 2021

Estriol USP41 Micro 25 Grams recall: CGMP Deviations

Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT by: Wuhan Fortune Chemical Co., Ltd., China, NDC: 46144-300-01

Why was Estriol USP41 Micro 25 Grams recalled?

cGMP Deviations

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 #: ETL181001, Exp 10/09/2021

Product
Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT by: Wuhan Fortune Chemical Co., Ltd., China, NDC: 46144-300-01
Recalling firm
API Solutions Inc.
Quantity
20 bottles
Distribution
AL, AZ, CO, FL, VA
Recall date
August 4, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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