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Prescription Drugs

💊 Drugs • 11,927 recalls

Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141.

NCS Healthcare of Kentucky

Class I - Dangerous

Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots

Oct 27, 2023 Prescription Drugs Nationwide View Details →

Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for ITF Pharma, Inc., Berwyn, PA 19312 USA NDC:70726-0303-1 (carton) and 70726-0303-2 (bottle)

ITF PHARMA

Class I - Dangerous

Failed Viscosity Specifications: Out-of-specification test results for viscosity

Oct 20, 2023 Prescription Drugs View Details →

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India,

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).

Oct 23, 2023 Prescription Drugs Nationwide View Details →

Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial NDC 51754-2131-1; Carton NDC 51754-2131-4).

Exela Pharma Sciences

Class I - Dangerous

Presence of Particulate Matter: Silicone

Oct 18, 2023 Prescription Drugs Nationwide View Details →

Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supply, 2011 W Cumberland St. Dunn, NC 28334.

Family Medical Supply

Class I - Dangerous

cGMP Deviations

Nov 9, 2023 Prescription Drugs Nationwide View Details →

Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01

Zydus Pharmaceuticals (USA)

Class I - Dangerous

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Oct 19, 2023 Prescription Drugs Nationwide View Details →

Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

Failed Dissolution Specifications

Oct 20, 2023 Prescription Drugs Nationwide View Details →

2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4903-11

Pfizer

Class I - Dangerous

Presence of Particulate Matter: identified as glass.

Oct 2, 2023 Prescription Drugs Nationwide View Details →

Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08.

VistaPharm

Class I - Dangerous

Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.

Oct 26, 2023 Prescription Drugs Nationwide View Details →

Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01.

Zydus Pharmaceuticals (USA)

Class I - Dangerous

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Oct 19, 2023 Prescription Drugs Nationwide View Details →

Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10

Amneal Pharmaceuticals of New York

Class I - Dangerous

Failed Dissolution Specifications

Oct 27, 2023 Prescription Drugs Nationwide View Details →

4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24

Pfizer

Class I - Dangerous

Presence of Particulate Matter: identified as glass.

Oct 2, 2023 Prescription Drugs Nationwide View Details →

Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1

Taro Pharmaceuticals

Class I - Dangerous

Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.

Nov 6, 2023 Prescription Drugs Nationwide View Details →

Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05

PAR Sterile Products

Class I - Dangerous

Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.

Nov 9, 2021 Prescription Drugs Nationwide View Details →

Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.

Dr. Reddy's Laboratories

Class I - Dangerous

Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.

Oct 13, 2023 Prescription Drugs Nationwide View Details →

Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-256-01.

Zydus Pharmaceuticals (USA)

Class I - Dangerous

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Oct 19, 2023 Prescription Drugs Nationwide View Details →

Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11

AbbVie

Class I - Dangerous

Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.

Oct 17, 2023 Prescription Drugs View Details →

Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11

Zyla Life Sciences US

Class I - Dangerous

Sub-potent Drug: Lower potency than labeled.

Oct 20, 2023 Prescription Drugs Nationwide View Details →

Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

Failed Dissolution Specifications: Out of specification for dissolution.

Oct 23, 2023 Prescription Drugs Nationwide View Details →

1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4904-11

Pfizer

Class I - Dangerous

Presence of Particulate Matter: identified as glass.

Oct 2, 2023 Prescription Drugs Nationwide View Details →

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