Prescription medicine recalls

Amerisource Health Services LLC — Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only

Superpotent drug: Assay results were slightly above specification at the time zero point.

Pfizer Inc. — Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake FOrest, IL 60045, NDC 0409-4911-11 (carton), 0409-4911-34 (case).

Presence of Particulate Matter; identified as glass

PFIZER — Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only

Presence of particulate matter: glass

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company — Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceuticals Corp. Tarrytown, NY 10591, USA, A Prestige Con

Chemical Contamination: presence of benzene

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.

Pfizer Inc. — 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton), 0409

Presence of Particulate Matter; identified as glass

Pfizer Inc. — 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL Syringe per Carton, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6637-24 (carton), 0409-6637-14

Presence of Particulate Matter; identified as glass

Lupin Pharmaceuticals Inc. — Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only

CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.

Dr. Reddy's Laboratories, Inc. — Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only

Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.

GlaxoSmithKline LLC — ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only

Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification

Fagron, Inc — NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-4, Bar code 3 51552 00414 6

Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Fagron, Inc — NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-3, Bar code 3 51552 00413 9

Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Legacy Pharmaceutical Packaging LLC — Sertraline Tablets, USP 100 mg, 30 tablets per bottle

CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.

Fagron, Inc — NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3

Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Fagron, Inc — NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-1, Bar code 3 51552 00411 5

Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Azurity Pharmaceuticals, Inc. — Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only

Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine…

SUN PHARMACEUTICAL INDUSTRIES INC — Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only

Failed Impurities/Degradation Specifications

STAQ Pharma, Inc. — ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50, Denver, Colorado 80239, NDC 73177-0109-26

STAQ Pharma Inc.

Wells Pharma of Houston LLC — ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10

Lack of assurance of sterility.

AnazaoHealth Corporation — B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML Sterile Multiple-Dose Vial, Rx only, AnazaoHealth, 7465 W Sunset Rd #1200, Las Vegas, NV 89113

Presence of Particulate Matter.

Novartis Pharmaceuticals Corporation — SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals