Prescription medicine recalls

Teva Pharmaceuticals USA, Inc — Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapt

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the…

Lannett Company Inc. — Primidone Tablets USP, 250mg, 100-count bottle, Rx only

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Lupin Pharmaceuticals Inc. — Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only

Presence of particulate matter: a white thread-like structure in the cartridge

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.

Wisconsin Pharmacal Company — MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g)

Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.

JB Chemicals and Pharmaceuticals Ltd — Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only

Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test

CareFusion 213, LLC — BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.

Lack of assurance of Sterility: potential product contamination

CareFusion 213, LLC — BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Bec

Lack of assurance of Sterility: potential product contamination

Alcon Research LLC — Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

Alcon Research LLC — GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz)

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heig

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

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.

SCOPE HEALTH — Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile

Lack of Assurance of Sterility

Acella Pharmaceuticals, LLC — NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles

Chemical contamination; presence of lead and lithium above specification

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.

Harrow Eye LLC — FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.

Lack of Assurance of Sterility

American Regent, Inc. — Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01

Labeling: Missing Label

Premier Dental Products Co — Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.

Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914…

Unichem Pharmaceuticals USA Inc. — busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only

Subpotent drug

The Harvard Drug Group LLC — Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06

Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

Blaine Labs Inc — TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL)

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Blaine Labs Inc — Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Blaine Labs Inc — TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap

CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated