PlainRecalls
FDA Drug Moderate Class II Terminated

Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable NDC 69699-1332-05 b) (LYO) Powder NDC 69699-1332-05, Pharm D Solutions, Houston, Texas

Reported: November 7, 2018 Initiated: September 10, 2018 #D-0191-2019

Product Description

Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable NDC 69699-1332-05 b) (LYO) Powder NDC 69699-1332-05, Pharm D Solutions, Houston, Texas

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Pharm D Solutions, LLC
Units Affected
609 vials
Distribution
Nationwide
Location
Houston, TX

Frequently Asked Questions

What product was recalled?
Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable NDC 69699-1332-05 b) (LYO) Powder NDC 69699-1332-05, Pharm D Solutions, Houston, Texas. Recalled by Pharm D Solutions, LLC. Units affected: 609 vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on November 7, 2018. Severity: Moderate. Recall number: D-0191-2019.