PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: October 12, 2016 Initiated: September 12, 2016 #D-0003-2017

Product Description

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

Reason for Recall

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

Details

Recalling Firm
The Apothecary Shoppe LLC
Units Affected
455 mL total volume
Distribution
Oklahoma
Location
Tulsa, OK

Frequently Asked Questions

What product was recalled?
Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK. Recalled by The Apothecary Shoppe LLC. Units affected: 455 mL total volume.
Why was this product recalled?
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Which agency issued this recall?
This recall was issued by the FDA Drug on October 12, 2016. Severity: Moderate. Recall number: D-0003-2017.