PlainRecalls
FDA Drug Moderate Class II Terminated

Papaverine HCl 30 mg, Phentolamine Mesylate 0.5 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

Reported: June 25, 2014 Initiated: May 12, 2014 #D-1402-2014

Product Description

Papaverine HCl 30 mg, Phentolamine Mesylate 0.5 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

Reason for Recall

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Details

Recalling Firm
John W Hollis Inc
Units Affected
25 mL
Distribution
Nationwide
Location
Nashville, TN

Frequently Asked Questions

What product was recalled?
Papaverine HCl 30 mg, Phentolamine Mesylate 0.5 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234. Recalled by John W Hollis Inc. Units affected: 25 mL.
Why was this product recalled?
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 25, 2014. Severity: Moderate. Recall number: D-1402-2014.