Prescription medicine recalls

Glenmark Pharmaceuticals Inc., USA — Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkel

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Amgen, Inc. — Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-530-01 (vial), NDC

Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.

Amgen, Inc. — Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc. Thousand Oaks, CA 91320, NDC 55513

Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.

A-S Medication Solutions LLC — METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3.

Presence of Foreign Tablets/Capsules.

MYLAN PHARMACEUTICALS INC — Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only

Failed Dissolution Specifications - low dissolution results

Denison Pharmaceuticals, LLC — Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube

Chemical Contamination: Presence of benzene.

Kowa Pharmaceuticals America — Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only

Presence of foreign tablets/capsules

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.

Imprimis NJOF, LLC — Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.

Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.

Central Admixture Pharmacy Services, Inc. — PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, N

Presence of Particulate Matter

Turbare Manufacturing — Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72

Lack of Assurance of Sterility: due to a quality control process deviation

Safecor Health, LLC — Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750.

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Safecor Health, LLC — Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

MEDLINE INDUSTRIES, LP - Northfield — CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only

Subpotent Drug

MEDLINE INDUSTRIES, LP - Northfield — Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com

Subpotent Drug

Safecor Health, LLC — Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784.

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

CareFusion 213, LLC — BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton

Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.

Zydus Pharmaceuticals (USA) Inc — Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only

Failed Impurities/Degradation Specifications

Zydus Pharmaceuticals (USA) Inc — Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only

Failed Impurities/Degradation Specifications

ICU Medical, Inc. — POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269

Labeling: Label Error on Declared Strength.