Franck's Lab Recalls Sterile DMPS Injectable Drugs Due to Contamination
Franck's Lab Inc. is recalling sterile DMPS injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room where they 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 sterile injectable drugs contaminated with microorganisms and fungal growth, which poses a significant risk of serious injury or infection to patients.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling four sterile DMPS injectable products. The affected products are DMPS 250mg/10ml Injectable (20 ml, 30 ml) and DMPS 50mg/ml (500mg/10ml) Injectable (10 ml, 5 ml). A total of 6 units 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 these sterile products were prepared. This lack of assurance of sterility poses a risk to patients using the injectable drugs.
Consumers and healthcare providers should stop using the recalled products and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication. The specific prescription numbers associated with the recall are 0405733, 0353173, 0349837, and 0392673.
The recalled product
- Product
- DMPS 250MG/10ML INJECTABLE 20 ML, 30 ML; DMPS 50MG/ML (500MG/10ML) INJECTABLE 10 ML, 5 ML (4 DIFFERENT PRODUCTS)
- Category
- Drug — Sterile Injectable
- Affected units
- 6
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: 0405733 0353173 0349837 0392673
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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