Recalls / Class II

Class IID-1568-2012

Product

MAGNESIUM CHLORIDE, PRESERVATIVE FREE 20% INJECTABLE 100 ML 1000 ML 500 ML 600 ML 750 ML; MAGNESIUM SULFATE 50% (500MG/ML) INJECTABLE 14 ML 20 ML 4 ML; MAGNESIUM SULFATE IN 5% DEXTROSE 1% (1GM/100ML) INJECTABLE 2400 ML; MAGNESIUM SULFATE IN 5% DEXTROSE 4% (2GM/50ML) INJECTABLE 1200 ML; MAGNESIUM SULFATE, P.F. 50% (500MG/ML) INJECTABLE 180 ML 240 ML 4 ML 6 ML (14 DIFFERENT PRODUCTS)

Affected lot / code info

Rx #'s: 0357871 0391634 0371936 0352518 0371936 0390747 0371936 0390747 0400018 0400326 0408192 0402171 0408101 0409503 0398622 0399780 0401796 0401796 0389109 0401003 0383611

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

Recalling firm

Firm

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

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1210 SW 33rd Avenue, Ocala, Florida 34474-5138

Distribution

Quantity

32 units

Distribution pattern

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

Timeline

Recall initiated

2012-05-21

FDA classified

2012-08-10

Posted by FDA

2012-08-22

Terminated

2014-08-15

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1568-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.