FDAClass IISeptember 18, 2013

Oxytocin 10 Units/ml recall: Sterility Concern

OXYTOCIN 10 UNITS/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra…

Why was Oxytocin 10 Units/ml recalled?

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted 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?

03212013@12, 01112013@20, 03072013@19, and 05082013@27

Product
OXYTOCIN 10 UNITS/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra…
Recalling firm
Beacon Hill Medical Pharmacy, P.C.
Quantity
N/A
Distribution
USA nationwide
Recall date
September 18, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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