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.

MITOMYCIN 1MG/ML SOLUTION 160 ML 40 ML 80 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 21, 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

MITOMYCIN 1MG/ML SOLUTION 160 ML 40 ML 80 ML; MITOMYCIN SOLUTION, STERILE 0.02% (200MCG/ML) OPHTHALMIC 0.5 ML 1 ML 1.5 ML 10 ML 12.5 ML 2 ML 2.5 ML 3 ML 30 ML 4 ML 5 ML 6 ML 7 ML; MITOMYCIN SOLUTION, STERILE 0.025% (250MCG/ML) OPHTHALMIC 2 ML 3 ML 4 ML 6 ML MITOMYCIN SOLUTION, STERILE 0.03% (300MCG/ML) OPHTHALMIC 2 ML 3 ML 4 ML 5 ML; MITOMYCIN SOLUTION, STERILE 0.04% (400MCG/ML) OPHTHALMIC 1 ML 10 ML 12 ML 2 ML 20 ML 3 ML 3.6 ML 4 ML 5 ML 5.4 ML 6 ML 7.2 ML; MITOMYCIN SOLUTION, STERILE 0.05% (500MCG/ML) OPHTHALMIC 1.5 ML 10 ML 15 ML 2 ML 3 ML 5 ML; MITOMYCIN SOLUTION, STERILE/BUFFERED 0.5MG/ML INJECTABLE 80 ML; MITOMYCIN, LYOPHILIZED 1MG INJECTABLE 1 VIAL 10 VIAL 12 VIAL 2 VIAL 2 VIALS 20 VIAL 20 vials 3 VIAL 3 VIALS 4 VIAL 4 VIALS 5 VIAL 5 VIALS 50 VIAL 6 VIAL 6 VIALS 8 VIAL 8 VIALS; MITOMYCIN, LYOPHILIZED (BUFFERED) 20MG INJECTABLE 1 VIAL 10 VIAL 12 VIAL 15 VIAL 16 VIAL 17 VIALS 18 VIAL 2 VIAL 20 VIAL 24 VIAL 24 VIALS 3 VIAL 30 VIAL 4 VIAL 5 VIAL 6 VIAL 6 VIALS 7 VIAL 7 VIALS 8 VIAL 8 VIALS; MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE 1 VIAL 1 VIALS 10 VIAL 10 VIALS 11 VIAL 12 VIAL 12 VIALS 13 VIAL 14 VIAL 15 `VIAL 15 VIAL 16 `VIAL 16 VIAL 17 `VIAL 18 VIAL 18 VIALS 2 `VIAL 2 VIAL 2 VIALS 20 VIAL 20 vials 23 `VIAL 23 VIAL 24 VIAL 3 VIAL 3 VIALS 30 VIAL 36 VIAL 4 VIAL 4 VIALS 40 VIAL 41 VIAL 5 VIAL 5 VIALS 50 VIAL 6 `VIAL 6 VIAL

Quantity: 1079 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. 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