Prescription drug oral solution recalled for microbial contamination
Bayer Healthcare Pharmaceuticals Inc. is recalling 192 bottles of VITRAKVI (larotrectinib) oral solution due to microbial contamination identified as Penicillium brevicompactum during routine testing.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: This is a FDA Class I recall, the most serious classification issued by the agency for drug products. FDA Class I recalls represent the minimum score of 4 per the severity rubric when no serious injuries or deaths have been reported.
Plain-English summary
Bayer Healthcare Pharmaceuticals Inc. is recalling VITRAKVI (larotrectinib) oral solution, 20 mg/mL, due to microbial contamination identified as Penicillium brevicompactum during routine stability testing. The recall involves 192 bottles of 100 mL product with lot number 2114228 (expiration date 02/29/2024, NDC 50419-392-01).
The contaminated product was distributed to specialty pharmacies and distributors nationwide. This is a Class I FDA recall, the agency's most serious classification for drug safety concerns.
Patients and healthcare providers can identify affected product using lot number 2114228 and expiration date 02/29/2024.
The recalled product
- Product
- VITRAKVI (LAROTRECTINIB)
- Brand
- VITRAKVI
- Manufacturer
- Bayer Healthcare Pharmaceuticals Inc.
- Category
- Drug
- Affected units
- 192
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 (2)
- Lot# 2114228
- EXP. 02/29/2024
Distribution
Distributed nationwide across the United States.
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