The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1611-2012·Announced 2012-08-22

Franck's Lab Recalls Ranibizumab Injectable Due to Sterility Concerns

Franck's Lab Inc. is recalling 19 units of Ranibizumab injectable because FDA testing found microorganisms in the clean room where the sterile drugs were prepared.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in injectable drugs, which poses a significant risk of infection or serious injury.

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
Affected units
19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 98 recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 98 products in this recall →

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