Drug product
CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
D-1068-2016
Product summary
- Event
- Event 73662
- Status
- Terminated
- Classification
- Class I
- Quantity
- N/A
- Official record key
drug-enforcement:D-1068-2016
Official wording
Reason: Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine
Code information: All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.
Distribution pattern: U.S. Including: CA, HI, NM
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up