Franck's Lab Recalls Sterile L-Tryptophan Injectable Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile L-Tryptophan injectable products distributed between November 2011 and May 2012 because FDA sampling 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 involves a lack of assurance of sterility in injectable drugs, which poses a risk of serious adverse health consequences such as infection, meeting the criteria for a Severe rating.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The specific product identified in the recall notice is L-Tryptophan 15mg/ml Injectable, 60 ml. The recall was initiated after FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where these sterile products were prepared.
The distribution of the affected products was nationwide and included the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the recalled L-Tryptophan injectable products and contact their pharmacist or the recalling firm for further instructions. The recall number is D-1567-2012.
The recalled product
- Product
- L-TRYPTOPHAN 15MG/ML INJECTABLE 60 ML (1 PRODUCT)
- Category
- Drug — Injectable Sterile Drug
- Affected units
- 1
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 #: 0399563
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.
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