Reliable Compounding Pharmacy Recalls Biotin Capsules Due to Labeling Error
Reliable Compounding Pharmacy is recalling Biotin 100 mg capsules because they were found to contain 4-aminopyridine instead of the labeled ingredient.
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: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Reliable Compounding Pharmacy is recalling CAP-BIOTIN 100 MG capsules due to a labeling error. The products were labeled as Biotin 100 mg but were found to contain 4-aminopyridine.
The recall covers all lots compounded between March 24, 2015, and March 24, 2016, that are within their expiration dates. The affected products were distributed in California, Hawaii, and New Mexico.
Consumers who have these products should stop using them and contact their pharmacist or healthcare provider for instructions on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
- Manufacturer
- Reliable Rexall-A Compounding Pharmacy
- Category
- Drug — Compounded Prescription
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)
- All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.
Distribution
Part of a larger recall action
This product is one of 70 recalled by Reliable Rexall-A Compounding Pharmacy 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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