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.

CHORIONIC GONADOTROPIN (STANDARD) - 21 DAY 200 UNIT VIALS KIT 1 KIT 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

CHORIONIC GONADOTROPIN (STANDARD) - 21 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD) - 45 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD)-21 DAY 125 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD)-45 DAY 125 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN + B12, LYOPHILIZED 4,000 UNIT/40MCG/ML KIT 1 KIT, 2 KIT, 3 KIT; CHORIONIC GONADOTROPIN + B12, LYOPHILIZED (HCG) 4,000 UNIT VIAL INJECTABLE 1 VIAL, 12 VIALS; CHORIONIC GONADOTROPIN KIT 5,000 UNIT VIAL INJECTABLE 1 KIT; CHORIONIC GONADOTROPIN** KIT 10,000 UNIT VIAL INJECTABLE 1 KIT; CHORIONIC GONADOTROPIN, HUMAN - MINI 250 UNITS TROCHE 30 TROCHE, 45 TROCHE, 50 TROCHE, 60 TROCHE, 80 TROCHE; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 1,000 UNIT VIAL INJECTABLE 30 VIAL; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL INJECTABLE 1 VIAL, 10 VIAL, 14 VIAL, 15 VIAL, 2 VIAL, 2 VIALS, 20 VIAL, 3 VIAL, 5 VIAL, 6 VIAL; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 125 UNIT VIAL (UNIT DOSE) INJECTABLE 10 VIAL, 14 VIAL, 15 VIAL, 2 VIAL, 24 VIAL, 28 VIAL, 28 VIALS, 7 VIAL, 7 VIALS; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 2,500 UNIT VIAL INJECTABLE 5 VIAL; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 200 UNIT VIAL (UNIT DOSE) INJECTABLE 22 VIAL, 25 VIAL, 8 VIAL (40 DIFFERENT PRODUCTS)

Quantity: 193 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