Franck's Lab Recalls Sterile Diclofenac Sodium Injectable Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile diclofenac sodium injectables distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the clean room.
What this means for you
Illness, injury, or structural failure has been reported. 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 the presence of microorganisms and fungal growth in sterile injectable drugs represents a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The specific products involved are Diclofenac Sodium, SDPF, in 0.1 mL syringes (30G, 1/2") with a concentration of 500 mcg/0.1 mL. The recall covers three different product sizes: 0.5 mL, 2 mL, and 4 mL.
The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where these sterile products were prepared. This lack of assurance of sterility poses a risk to patients who receive these injections.
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. Specific prescription numbers associated with the recall include 0392224, 0378833, 0402369, 0360916, and 0402369. Consumers and healthcare providers should stop using these products and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- DICLOFENAC SODIUM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 500MCG/0.1ML INJECTABLE 0.5 ML, 2 ML, 4 ML (3 DIFFERENT PRODUCTS)
- Category
- Drug — Sterile Injectable
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Rx #'s: 0392224 0378833 0402369 0360916 0402369
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 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.
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