Recalls / Class I
Class ID-1068-2016
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
- Affected lot / code info
- All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.
Why it was recalled
Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine
Recalling firm
- Firm
- Reliable Rexall-A Compounding Pharmacy
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 801 Irving St, N/A, San Francisco, California 94122-2310
Distribution
- Quantity
- N/A
- Distribution pattern
- U.S. Including: CA, HI, NM
Timeline
- Recall initiated
- 2016-03-25
- FDA classified
- 2016-07-06
- Posted by FDA
- 2016-07-13
- Terminated
- 2017-04-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1068-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.