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.

MIDAZOLAM 1MG/ML (5ML VIAL) INJECTABLE 100 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

MIDAZOLAM 1MG/ML (5ML VIAL) INJECTABLE 100 ML; MIDAZOLAM 1MG/ML INJECTABLE 100 ML 108 ML 1250 ML 20 ML 292 ML 300 ML 40 ML 500 ML 90 ML; MIDAZOLAM 5MG/ML INJECTABLE 140 ML 150 ML 200 ML; MIDAZOLAM HCL ***(10X10ML) 5MG/ML INJECTABLE 100 MLS (13 DIFFERENT PRODUCTS)

Quantity: 16 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