FDA recall D-1585-2012

Product

MORPHINE SULFATE 2MG/ML INJECTABLE 10 ML; MORPHINE SULFATE MDV 10MG/ML INJECTABLE 10 ML 25 ML 30 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 50MG/ML INTRATHECAL 18 ML 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 15MG/ML INTRATHECAL 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 20MG/ML INTRATHECAL 18 ML 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 25MG/ML INTRATHECAL 20 ML 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 38MG/ML INTRATHECAL 50 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 5MG/ML INTRATHECAL 40 ML; MORPHINE SULFATE, P.F. 10MG/ML INTRATHECAL 40 ML; MORPHINE SULFATE, P.F. 11.5MG/ML INTRATHECAL 35 ML; MORPHINE SULFATE, P.F. 1MG/ML INJECTABLE 250 ML; MORPHINE SULFATE, P.F. 25MG/ML INTRATHECAL 30 ML; MORPHINE SULFATE, P.F. 30MG/ML INTRATHECAL 18 ML; MORPHINE SULF

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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Distribution

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

Key facts

Status

Terminated

Initiation date

2012-05-21

Report date

2012-08-22

Termination date

2014-08-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ocala, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1585-2012