Franck's Lab Recalls Ranibizumab Injectable Due to Sterility Concerns

Plain-English summary

Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of 19 units of Ranibizumab, SDPF (0.05ML syringe, 31G, 5/16") 10MG/ML Injectable. The recall covers 18 different product variations with volumes ranging from 1 ML to 28.1 ML. These sterile human drugs were distributed between November 21, 2011, and May 21, 2012.

The recall was initiated due to a lack of assurance of sterility. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where the sterile products were prepared. The affected products were distributed nationwide as well as in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies.

Consumers and healthcare providers should stop using the affected Ranibizumab products and contact their healthcare provider or the recalling firm for further instructions. The recall is classified as FDA Class II.

The recalled product

Product

RANIBIZUMAB, SDPF - (0.05ML SYRINGE, 31G, 5/16") 10MG/ML INJECTABLE 1 ML 1.25 ML 1.75 ML 2.3 ML 2.35 ML 20 ML 20.15 ML 20.45 ML 20.6 ML 20.9 ML 21.05 ML 21.2 ML 21.25 ML 21.45 ML 21.6 ML 21.7 ML 24.4 ML 28.1 ML (18 DIFFERENT PRODUCTS)

Manufacturer

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

Category

Drug — Injectable

Hazard

• microbial-contamination
• fungal-growth
• sterility-failure

Affected units

19

Distribution

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