Prescription medicine recalls

Keystone Industries — M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml)

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…

Keystone Industries — Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…

Keystone Industries — safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…

Prescription medicine · Amerisource Health Services LLC · 37,916 bottles affected

Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

Prescription medicine · Amerisource Health Services LLC · 8,561 bottles affected

Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

Keystone Industries — Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml)

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…

Prescription medicine · Amerisource Health Services LLC · 23,490 bottles affected

Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

Food & drug recall · FDANovember 13, 2024Serious

Brands International Corporation — Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube

Prescription medicine · Brands International Corporation · unknown affected

CGMP Deviations: lack of adequate release testing.

Prescription medicine · American Regent, Inc.

American Regent, Inc. — Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517

Presence of Particulate Matter: Potential for glass delamination from the vials.

Prescription medicine · Safecor Health, LLC · 587 boxes affected

Safecor Health, LLC — Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Prescription medicine · American Regent, Inc.

American Regent, Inc. — Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only

Presence of Particulate Matter: Potential for glass delamination from the vials.

Prescription medicine · American Regent, Inc.

American Regent, Inc. — Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only

Presence of Particulate Matter: Potential for glass delamination from the vials.

Prescription medicine · Safecor Health, LLC · 791 boxes affected

Safecor Health, LLC — Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Food & drug recall · FDANovember 8, 2024Serious

ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only

Prescription medicine · ACCORD HEALTHCARE, INC.

Subpotent drug

Prescription medicine · Aurobindo Pharma USA Inc

Aurobindo Pharma USA Inc — Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Prescription medicine · Aurobindo Pharma USA Inc · 102576 bottles affected

Aurobindo Pharma USA Inc — Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Prescription medicine · The Harvard Drug Group LLC dba Major… · N/A affected

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70

Failed Impurity/Degradation Specifications

Prescription medicine · Aurobindo Pharma USA Inc · 3336 bottles affected

Aurobindo Pharma USA Inc — Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit