FDA Drug Moderate Class II Terminated

Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK

Reported: October 12, 2016 Initiated: September 12, 2016 #D-0004-2017

Product Description

Reason for Recall

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

Details

Recalling Firm: The Apothecary Shoppe LLC
Units Affected: 247.5 mL total volume
Distribution: Oklahoma
Location: Tulsa, OK

Frequently Asked Questions

What product was recalled? ▼

Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK. Recalled by The Apothecary Shoppe LLC. Units affected: 247.5 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-0004-2017.