D-1068-2016 Class I Terminated
FDA drug recall D-1068-2016 was initiated by Reliable Rexall-A Compounding Pharmacy on March 25, 2016 and is designated Class I. Reason for recall: Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine The recall status is terminated (terminated April 10, 2017). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- July 13, 2016
- Initiation Date
- March 25, 2016
- Termination Date
- April 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
Reason for Recall
Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine
Distribution Pattern
U.S. Including: CA, HI, NM
Code Information
All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.