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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Wockhardt Usa

Class I - Dangerous

CGMP Deviations: Firm did not adequately investigate customer complaints.

Apr 22, 2015 Prescription Drugs Nationwide View Details →

Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0990-01.

Wockhardt Usa

Class I - Dangerous

CGMP Deviations: Firm did not adequately investigate customer complaints.

Apr 22, 2015 Prescription Drugs Nationwide View Details →

Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Wockhardt Usa

Class I - Dangerous

CGMP Deviations: Firm did not adequately investigate customer complaints.

Apr 22, 2015 Prescription Drugs Nationwide View Details →

Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count Bottles (NDC: 64679-0736-03), and C) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0736-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC, 20 Waterview Blvd. Parsippany, NJ 07054 USA .

Wockhardt Usa

Class I - Dangerous

CGMP Deviations: Firm did not adequately investigate customer complaints.

Apr 22, 2015 Prescription Drugs Nationwide View Details →

Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B) 500 Count Bottles (NDC: 64679-953-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Wockhardt Usa

Class I - Dangerous

CGMP Deviations: Firm did not adequately investigate customer complaints.

Apr 22, 2015 Prescription Drugs Nationwide View Details →

Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0972-00.

Wockhardt Usa

Class I - Dangerous

CGMP Deviations: Firm did not adequately investigate customer complaints.

Apr 22, 2015 Prescription Drugs Nationwide View Details →

Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), and C) 1000 Count Bottles (NDC: 64679-929-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Wockhardt Usa

Class I - Dangerous

CGMP Deviations: Firm did not adequately investigate customer complaints.

Apr 22, 2015 Prescription Drugs Nationwide View Details →

Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10) Cartons. Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217. NDC: 68084-606-21.

American Health Packaging

Class I - Dangerous

Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.

Jun 26, 2015 Prescription Drugs Nationwide View Details →

Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-124-01

Kremers Urban Pharmaceuticals

Class I - Dangerous

Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.

Jul 7, 2015 Prescription Drugs Nationwide View Details →

Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20

Fresenius Kabi USA

Class I - Dangerous

Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation

Jun 4, 2015 Prescription Drugs Nationwide View Details →

KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49

Hospira

Class I - Dangerous

Crystallization; identified as calcium salt of Ketorolac

Jun 30, 2015 Other Drugs Nationwide View Details →

Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (NDC 54162-640-07), Rx Only, Manufactured by Geritrex Corporation, Mount Vernon, NY 10550

Geritrex

Class I - Dangerous

CGMP Deviation: Poor container closure of the bulk storage container

Jun 5, 2015 Prescription Drugs Nationwide View Details →

HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL

Qualitest Pharmaceuticals

Class I - Dangerous

Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable

Jun 29, 2015 Prescription Drugs Nationwide View Details →

KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49

Hospira

Class I - Dangerous

Crystallization; identified as calcium salt of Ketorolac

Jun 30, 2015 Other Drugs Nationwide View Details →

0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68

Hospira

Class I - Dangerous

Lack of assurance of sterility: Potential channel leaks near the threaded vial port.

Jul 2, 2015 Prescription Drugs View Details →

Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-123-01

Kremers Urban Pharmaceuticals

Class I - Dangerous

Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.

Jul 7, 2015 Prescription Drugs Nationwide View Details →

Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India, NDC 60505-0209-1

Apotex

Class I - Dangerous

Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.

May 29, 2015 Prescription Drugs Nationwide View Details →

Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5 blister packs per carton (NDC 68084-279-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

American Health Packaging

Class I - Dangerous

CGMP Deviations: Firm did not adequately investigate customer complaints.

Jun 1, 2015 Prescription Drugs Nationwide View Details →

Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC 68084-498-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

American Health Packaging

Class I - Dangerous

CGMP Deviations: Firm did not adequately investigate customer complaints.

Jun 1, 2015 Prescription Drugs Nationwide View Details →

Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11); 5 blister packs per carton (NDC 68084-008-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

American Health Packaging

Class I - Dangerous

CGMP Deviations: Firm did not adequately investigate customer complaints.

Jun 1, 2015 Prescription Drugs Nationwide View Details →