FDAClass IIDecember 3, 2014

HCG Low Dose 10 IU / recall: Sterility Concern

HCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2596-17

Why was HCG Low Dose 10 IU / recalled?

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

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?

141010I, 11/10/14; 141017F, 11/17/14;

Product
HCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2596-17
Recalling firm
Perry Drug Inc.
Quantity
2 vials
Distribution
Kansas and Missouri
Recall date
December 3, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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