Home / Recalls / Franck's Lab Inc., d.b.a. Franck's Compounding Lab / D-1494-2012

D-1494-2012 Class II Terminated

Recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab — Ocala, FL

Recall Details

Product Type: Drugs
Report Date: August 22, 2012
Initiation Date: May 25, 2012
Termination Date: August 13, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 40 units

Product Description

CYCLOSPORINE (A) AQUEOUS (HUMAN) 0.5% OPHTHALMIC 10 ML, 5 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 0.2% OPHTHALMIC 10 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 1% OPHTHALMIC 10 ML; CYCLOSPORINE (A) CORN OIL SOLUTION 2% OPHTHALMIC 15 ML; CYCLOSPORINE (A) OIL SOLUTION 1% OPHTHALMIC 10 ML, 20 ML, 60 ML; CYCLOSPORINE (A) OIL SOLUTION 2% OPHTHALMIC 10 ML, 15 ML, 20 ML, 30 ML (12 DIFFERENT PRODUCTS)

Reason for Recall

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.

Distribution Pattern

Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

Code Information

Rx #'s: 0398633 0374138 0407059 0395611 0366358 0382466 0385492 0405984 0407947 0409833 0369221 0401142 0364989 0385219 0389327 0389381 0395535 0402826 0406693

Other recalls by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

D-1527-2012 Class II — G-C-P 0.1%/0.1%/0.05% SOLUTION 250 ML, 250 MLS, 500 ML (3 DIFFERENT PRODUCTS) (May 25, 2012)
D-1492-2012 Class II — CYCLOPENT/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%/2.5%/1%/0.5% OPHTHALMIC 5 ML (1 (May 25, 2012)
D-1453-2012 Class II — ALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML; ALT (May 25, 2012)
D-1541-2012 Class II — HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHECAL (May 25, 2012)
D-1512-2012 Class II — EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM DI (May 25, 2012)
D-1533-2012 Class II — HYALURONIC ACID SODIUM SALT 10MG/ML INJECTABLE 100 ML, 20 ML; HYALURONIC ACID S (May 25, 2012)
D-1448-2012 Class II — ACETIC ACID, IRRIGATION 3% SOLUTION 500 ML (1 PRODUCT) (May 25, 2012)
D-1485-2012 Class II — CISPLATIN 1MG/ML INJECTABLE 1000 ML, 2000 ML (2 DIFFERENT PRODUCTS) (May 25, 2012)
D-1481-2012 Class II — CEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML; CEFAZOLIN VIAL*(25X1GM) (May 25, 2012)
D-1515-2012 Class II — ESTRADIOL 25MG PELLETS 1 PELLET, 15 PEL, 15 PELLET, 2 PELLET, 2 TAB, 3 PELLET, 4 (May 25, 2012)