Recalls / Class II

Class IID-1552-2012

Product

KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE 10 ML 24 ML 500 ML; KETOROLAC TROMETHAMINE 60MG/ML INJECTABLE 48 ML; KETOROLAC TROMETHAMINE, 1ML SDV**25X1ML 30MG/ML INJECTABLE 50 ML 75 ML; KETOROLAC TROMETHAMINE, P.F. 60MG/ML INJECTABLE 10 ML (7 DIFFERENT PRODUCTS)

Affected lot / code info

Rx #'s: 0407225 0407852 0405175 0408193 0403243 0404737 0392573 0392575 0392577 0392575 0401951 0404831

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

14 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-1552-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.