Class II · Moderate risk Ongoing
Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason Lack of Assurance of Sterility
Is Biotin recalled?
15 FDA recalls mention Biotin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Biotin.
Class II · Moderate risk Ongoing
Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY…
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Minoxidil/Biotin 1.25mg/5mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866)…
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
D-Biotin 300 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I · High risk Terminated
Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a compounded drug not for resale, Store at…
Reason Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.
Class II · Moderate risk Terminated
Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Finasteride/Biotin 1 mg/50 mcg
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class III · Low risk Terminated
Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630.
Reason Failed pH Specification: product does not meet pH label claim.
Class II · Moderate risk Terminated
Biotin Suspension 10mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119…
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk Terminated
Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8142-2); c) 5g…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Class I · High risk Terminated
CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
Reason Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine
Class II · Moderate risk Terminated
Biotin10 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, the Compounding Pharmacy of America, Knoxville, TN
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk Terminated
Biotin Injection, all strengths and all presentations including Biotin-15-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa…
Reason Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility…
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