FDA Recall D-1068-2016
Reliable Rexall-A Compounding Pharmacy · San Francisco, CA
Class I — life-threatening Terminated 381 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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
Recall record
- Recall number
D-1068-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- U.S. Including: CA, HI, NM
- Recall initiated
- 2016-03-25
- Classified by FDA Center
- 2016-07-06
- FDA published
- 2016-07-13
- Terminated
- 2017-04-10
- Recalling firm
- Reliable Rexall-A Compounding Pharmacy
- Firm location
- San Francisco, CA