Prescription medicine recalls

Prescription medicine · Viatris Inc · 118,324 bottles affected

Viatris Inc — Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), Rx only

Superpotent Drug and Subpotent Drug: potency failures obtained

Prescription medicine · Viatris Inc · 55,032 bottles affected

Viatris Inc — Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10), Rx only

Superpotent Drug and Subpotent Drug: potency failures obtained

Prescription medicine · Viatris Inc · 9,828 bottles affected

Viatris Inc — Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only

Superpotent Drug and Subpotent Drug: potency failures obtained

Food & drug recall · FDANovember 18, 2024Highest risk

Endo USA, Inc. — Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each)

Prescription medicine · Endo USA, Inc. · 8,029 cartons affected

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled.

Prescription medicine · Viatris Inc · 34,845 bottes affected

Viatris Inc — Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (NDC 0378-1800-10), Rx only

Superpotent Drug and Subpotent Drug: potency failures obtained

Food & drug recall · FDANovember 18, 2024Highest risk

Endo USA, Inc. — Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each

Prescription medicine · Endo USA, Inc. · 9,816 cartons affected

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled.

Prescription medicine · Viatris Inc · 42,331 bottles affected

Viatris Inc — Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only

Superpotent Drug and Subpotent Drug: potency failures obtained

Prescription medicine · Viatris Inc · 19, 549 bottles affected

Viatris Inc — Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10), Rx only

Superpotent Drug and Subpotent Drug: potency failures obtained

Prescription medicine · Viatris Inc · 43,765 bottles affected

Viatris Inc — Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10), Rx only

Superpotent Drug and Subpotent Drug: potency failures obtained

Food & drug recall · FDANovember 18, 2024Highest risk

Endo USA, Inc. — Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each)

Prescription medicine · Endo USA, Inc. · 72,973 cartons affected

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled.

Food & drug recall · FDANovember 15, 2024Serious

Evaric Pharmaceuticals Inc. — Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only

Prescription medicine · Evaric Pharmaceuticals Inc. · 222, 600 bottles affected

Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.

Keystone Industries — Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.

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 — Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml)

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 — Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), 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 — Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford Road, La Vergne, TN 37086, www.quala.com

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 — Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g)

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 — Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml)

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 — Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.

Food & drug recall · FDANovember 14, 2024Labelling issue

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

Zydus Pharmaceuticals (USA) Inc — Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · 4404 packs affected

Labeling: Not Elsewhere Classified - Wrong NDC number

Keystone Industries — Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL)