Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling 448 units of BIMIX sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms 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 hazard involves sterile injectable drugs contaminated with microorganisms, which carries a significant risk of serious injury or hospitalization.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of 448 units of BIMIX sterile injectable drugs. The affected products include various concentrations and volumes of BIMIX and BIMIX, SDSM injectables. These products were distributed nationwide and to the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies between November 21, 2011, and May 21, 2012.
The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. This lack of assurance of sterility poses a risk of infection to patients who receive these injectable drugs.
Patients and healthcare providers should stop using the affected products immediately. Consumers should check their medication records for the specific prescription numbers listed in the recall notice and contact their healthcare provider or pharmacist for guidance on alternative treatments or further instructions.
The recalled product
- Product
- BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG / 5MG INJECTABLE 10 ML; BIMIX 9MG / 0.25MG INJECTABLE 10 ML, 5 ML; BIMIX 15MG / 1MG INJECTABLE 10 ML; BIMIX 18MG / 0.5MG INJECTABLE 10 ML, 5 ML; BIMIX 18MG / 1MG INJECTABLE 5 ML; BIMIX 20MG / 0.75MG INJECTABLE 5 ML; BI
- Category
- Drug — Sterile Injectable
- Affected units
- 448
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 (20)
- Rx #'s: 0384355
- 0389246
- 0392332
- 0399800
- 0407377
- 0385460
- 0389158
- 0402762
- 0359057
- 0385462
- 0396242
- 0391321
- 0372399
- 0400437
- 388360
- 0350745
- 0354900
- 0357950
- 0365803
- 0391686
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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