FDAClass IIOctober 22, 2014

Hydroxyprogesterone Caproate 250 Mg/ml recall

HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.

Why was Hydroxyprogesterone Caproate 250 Mg/ml recalled?

Crystallization: Formation of crystals observed in product.

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# 12-20140207@109; Exp. 12/14 Lot# 12-20142107@82; Exp. 01/15

Product
HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.
Recalling firm
Avella of Deer Valley, Inc.
Quantity
197 vials
Distribution
Nationwide
Recall date
October 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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