Prescription medicine recalls

Glenmark Pharmaceuticals Inc., USA — Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only

CGMP Deviations

FDC Limited — Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only

Defective container; yellow colored spike from cap lodged in the nozzle

Endo Pharmaceuticals, Inc. — Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg.

SUN PHARMACEUTICAL INDUSTRIES INC — Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle

Failed Dissolution Specifications

TAILSTORM HEALTH INC — Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3

Subpotent Drug: reduced efficacy for epinephrine

Zydus Pharmaceuticals (USA) Inc — Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-7; (b) 5x2 mL Single-Dose Vial per carton, Vi

Cross contamination with other products.

Novel Laboratories, Inc. d.b.a Lupin Somerset — PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.015 g/ 5.9 g / 4.7 g, 3 pouches/carton, Rx only, Dist

Defective container: potential for non-sealed pouches which can lead to product leakage.

Zydus Pharmaceuticals (USA) Inc — Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only

Cross contamination with other products.

Zydus Pharmaceuticals (USA) Inc — Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only

Cross contamination with other products

SUN PHARMACEUTICAL INDUSTRIES INC — Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial

CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.

Zydus Pharmaceuticals (USA) Inc — Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only

Cross contamination with other products

Teva Pharmaceuticals USA, Inc — Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle

Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the…

Glenmark Pharmaceuticals Inc., USA — Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only

Failed Dissolution Specifications: results below specifications

Zydus Pharmaceuticals (USA) Inc — Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only

Presence of particulate matter: glass

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.

Medisca Inc. — Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.

CGMP Deviations and Presence of Particulate Matter: Glass

RemedyRepack Inc. — Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1203-03

CGMP Deviations: Out of specification for dissolution

Dr. Reddy's Laboratories, Inc. — Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India NDC 43598-478-90

Labeling: Incorrect or Missing Lot and/or Exp Date.

GLOBAL WIDGET LLC — Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

GLOBAL WIDGET LLC — Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

Amerisource Health Services LLC — Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only

Failed Dissolution Specifications