Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ALPROSTADIL 10MCG/ML INJECTABLE 10 ML Recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab Due to Lack of Assurance of Sterility: Franck's Lab Inc....

Date: May 25, 2012
Company: Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Franck's Lab Inc., d.b.a. Franck's Compounding Lab directly.

Affected Products

ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML; ALPROSTADIL 15MCG/ML INJECTABLE 5 ML; ALPROSTADIL 20MCG/ML INJECTABLE 10 ML, 10 MLS, 20 ML, 3 ML, 30 ML, 4 ML, 40 ML, 5 ML, 6 ML; ALPROSTADIL 24MCG/ML INJECTABLE 6 ML; ALPROSTADIL 25MCG/ML INJECTABLE 10 ML; ALPROSTADIL 30MCG/ML INJECTABLE 10 ML; ALPROSTADIL 35MCG/ML INJECTABLE 10 ML; ALPROSTADIL 40MCG/ML INJECTABLE 10 ML, 10 ML, 10 VIAL, 15 ML, 2 ML, 20 ML, 3 ML, 30 ML, 40 ML, 5 ML, 50 ML, 6 ML; ALPROSTADIL 50MCG/ML INJECTABLE 10 ML, 2 ML, 20 ML, 5 ML; ALPROSTADIL 60MCG/ML INJECTABLE 20 ML; ALPROSTADIL (M) 500MCG/ML INJECTABLE 10 ML; ALPROSTADIL 100MCG/ML INJECTABLE 5 ML; ALPROSTADIL, STERILE 1,000MCG/ML GEL 10 ML, 12 ML, 20 ML, 3 ML, 30 ML, 6 ML; ALPROSTADIL/PAPAVERINE 10MCG/9MG/ML INJECTABLE; ALPROSTADIL/PHENT 10MCG/0.5MG/ML INJECTABLE 10 ML, 5 ML; ALPROSTADIL/PHENT 17MCG/0.5MG/ML INJECTABLE 10 ML; ALPROSTADIL/PHENTOLAMINE 40MCG/2MG/ML INJECTABLE 10 ML (50 DIFFERENT PRODUCTS)

Quantity: 529 units

Why Was This Recalled?

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Franck's Lab Inc., d.b.a. Franck's Compounding Lab has 198 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report