FDAClass IIAugust 12, 2015

SIH-Hydroxyprogesterone Caproate 250 recall: Sterility Concern

SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135

Why was SIH-Hydroxyprogesterone Caproate 250 recalled?

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

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 #: 04222015@20, BUD 08/30/2015

Product
SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
Recalling firm
The Apothecary Shoppe LLC
Quantity
34 mL
Distribution
Oklahoma
Recall date
August 12, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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