Prescription medicine recalls

Ajanta Pharma Ltd. — Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term…

Zydus Pharmaceuticals (USA) Inc — Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only

CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit

Ajanta Pharma Ltd. — Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term…

Ajanta Pharma Ltd. — Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term…

Zydus Pharmaceuticals (USA) Inc — Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only

CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit

B BRAUN MEDICAL INC — Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.

Presence of Particulate Matter.

Golden State Medical Supply Inc. — Primidone Tablets, USP, 50 mg, 50-count bottle, RX only

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

Golden State Medical Supply Inc. — Primidone Tablets, USP, 250 mg, 100-count bottle, RX only

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

Ascend Laboratories, LLC — Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only

Failed Dissolution Specifications

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.

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.

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.

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…

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 — 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.

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.

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.