FDAClass IIOctober 12, 2016

Phenotolamine 0.4mg/Prostaglandin 20mcg/mL recall: Sterility Concern

Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK

Why was Phenotolamine 0.4mg/Prostaglandin 20mcg/mL recalled?

Lack of Assurance of Sterility; medication was sterilized with a recalled filter

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?

05162016@18 BUD 09/13/2016; 07052016@9 BUD 11/02/2016; 08032016@13 BUD 12/01/2016

Product
Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
Recalling firm
The Apothecary Shoppe LLC
Quantity
455 mL total volume
Distribution
Oklahoma
Recall date
October 12, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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