PROGESTERONE AQUEOUS 2MG/ML INJECTABLE 3 ML; PROGESTERONE IN COTTONSEED OIL 50MG/ML INJECTABLE 30 ML; PROGESTERONE IN SESAME OIL 100MG/ML INJECTABLE 200 ML; PROGESTERONE IN SESAME OIL 150MG/ML INJECTABLE 1000 ML; PROGESTERONE IN SESAME OIL 50MG/ML INJECTABLE 10 MLS 30 ML (6 DIFFERENT PRODUCTS)

Recall Number: D-1608-2012

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

Classification: Class II

Status: Terminated

Report Date: 20120822

Initiation Date: 20120521

Termination Date: 20140815

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.

PROGESTERONE AQUEOUS 2MG/ML INJECTABLE 3 ML; PROGESTERONE IN COTTONSEED OIL 50MG/ML INJECTABLE 30 ML; PROGESTERONE IN SESAME OIL 100MG/ML INJECTABLE 200 ML; PROGESTERONE IN SESAME OIL 150MG/ML INJECTABLE 1000 ML; PROGESTERONE IN SESAME OIL 50MG/ML INJECTABLE 10 MLS 30 ML (6 DIFFERENT PRODUCTS)