Prescription medicine recalls

Major Pharmaceuticals — Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6950-61

Subpotent Drug

CareFusion 213, LLC — BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton

Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator

Ascend Laboratories, LLC — Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only

Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

Chiesi USA, Inc. — CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only

Lack of Assurance of Sterility

Supernus Pharmaceuticals, Inc. — Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only

Failed Dissolution Specifications

MYLAN PHARMACEUTICALS INC — Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only

Presence of precipitate

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Victory Medical Center Pharmacy — Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Ascend Laboratories, LLC — Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only

Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II,…

Ascend Laboratories, LLC — Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only

Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II,…

Cipla USA, Inc. — Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

Cipla USA, Inc. — Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

Cipla USA, Inc. — Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

Lannett Company Inc. — Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules

Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.

Bionpharma Inc. — Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only

Presence of Foreign Tablets/Capsules

Bell Pharmaceuticals, Inc — AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34)

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Bell Pharmaceuticals, Inc — Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Plea

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Bell Pharmaceuticals, Inc — meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Bell Pharmaceuticals, Inc — LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Bell Pharmaceuticals, Inc — GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05)

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Bell Pharmaceuticals, Inc — CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).