US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 25, 2012 (14 years ago)

Chorionic Gonadotropin (standard) - 21 Day 200 Unit Vials Kit 1 Kit; Chorionic…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was 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.

What was recalled

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)

Recalling firm
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1483-2012

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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