ALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML; ALTEPLASE, SDPF - (0.15ML LL SYRINGE, NO NEEDLE) 100MCG/ML (10MCG/0.1ML) INJECTA 0.15 ML, 0.3 ML; ALTEPLASE, SDPF - (0.1ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.1 ML, 0.2 ML, 0.3 ML; ALTEPLASE, SDPF - (0.1ML SYRINGE, 30G, 1/2") 100MCG/ML (10MCG/0.1ML) INJECTABLE 0.1 ML, 0.3 ML; ALTEPLASE, SDPF - (0.1ML SYRINGE, 30G, 1/2") 250MCG/ML (25MCG/0.1ML) INJECTABLE 0.1 ML (9 DIFFERENT PRODUCTS)

Recall Number: D-1453-2012

Firm: Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Classification: Class II

Status: Terminated

Report Date: 20120822

Initiation Date: 20120525

Termination Date: 20140813

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.

ALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML; ALTEPLASE, SDPF - (0.15ML LL SYRINGE, NO NEEDLE) 100MCG/ML (10MCG/0.1ML) INJECTA 0.15 ML, 0.3 ML; ALTEPLASE, SDPF - (0.1ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.1 ML, 0.2 ML, 0.3 ML; ALTEPLASE, SDPF - (0.1ML SYRINGE, 30G, 1/2") 100MCG/ML (10MCG/0.1ML) INJECTABLE 0.1 ML, 0.3 ML; ALTEPLASE, SDPF - (0.1ML SYRINGE, 30G, 1/2") 250MCG/ML (25MCG/0.1ML) INJECTABLE 0.1 ML (9 DIFFERENT PRODUCTS)