Biotin for Injection
Lack of Assurance of Sterility
Class I — High risk. Reasonable probability of serious harm or death.
Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
Drug: Biotin
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls
Lack of Processing Controls
Lack of Processing Controls
Lack of Processing Controls
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