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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56.

Teva Pharmaceuticals USA

Class I - Dangerous

Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.

Sep 22, 2016 Prescription Drugs Nationwide View Details →

Super Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box.

SOS Telecom

Class I - Dangerous

Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements

May 12, 2016 Prescription Drugs View Details →

Ginseng Power-X , 1800 mg, 1 capsule per pack , 24 single packs per box.

SOS Telecom

Class I - Dangerous

Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements

May 12, 2016 Prescription Drugs View Details →

Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle

Dream Body Weight Loss

Class I - Dangerous

Marketed without an approved NDA/ANDA: Undeclared sibutramine.

Jul 1, 2016 Prescription Drugs View Details →

Dream Body Advanced 400 mg 30 capsules in brown foil packets.

Dream Body Weight Loss

Class I - Dangerous

Marketed without an approved NDA/ANDA: Undeclared sibutramine.

Jul 1, 2016 Prescription Drugs View Details →

Dream Body 450 mg 30 capsules in a plastic screw on top bottle

Dream Body Weight Loss

Class I - Dangerous

Marketed without an approved NDA/ANDA: Undeclared sibutramine.

Jul 1, 2016 Prescription Drugs View Details →

PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7656-56.

Teva Pharmaceuticals USA

Class I - Dangerous

Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.

Sep 22, 2016 Prescription Drugs Nationwide View Details →

Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box

SOS Telecom

Class I - Dangerous

Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements

May 12, 2016 Prescription Drugs View Details →

Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, Rx Only, 20 tablets per carton (ten 2 count blister packs), Distributed by Arbor Pharmaceuticals, LLC Atlanta, GA 30328, NDC 24338-700-10.

Arbor Pharmaceuticals

Class I - Dangerous

Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging.

Jul 21, 2016 Prescription Drugs View Details →

Ninja-X, 4200 mg, 1 capsule per pack, 24 single packs per box.

SOS Telecom

Class I - Dangerous

Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements

May 12, 2016 Prescription Drugs View Details →

morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3353.

Pharmedium Services

Class I - Dangerous

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Jul 17, 2015 Prescription Drugs Nationwide View Details →

ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3234.

Pharmedium Services

Class I - Dangerous

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Jul 17, 2015 Prescription Drugs Nationwide View Details →

HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6165

Pharmedium Services

Class I - Dangerous

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Jul 17, 2015 Prescription Drugs Nationwide View Details →

Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-017-38

Leiter's Compounding

Class I - Dangerous

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Sep 20, 2016 Prescription Drugs Nationwide View Details →

rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3321.

Pharmedium Services

Class I - Dangerous

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Jul 17, 2015 Prescription Drugs Nationwide View Details →

morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6455.

Pharmedium Services

Class I - Dangerous

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Jul 17, 2015 Prescription Drugs Nationwide View Details →

lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume, Product code 2R3441, NDC 61553-441-80

Pharmedium Services

Class I - Dangerous

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Jul 17, 2015 Other Drugs Nationwide View Details →

fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.

Pharmedium Services

Class I - Dangerous

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Jul 17, 2015 Prescription Drugs Nationwide View Details →

Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85

The Harvard Drug Group

Class I - Dangerous

Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia

Jul 15, 2016 Other Drugs Nationwide View Details →

fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3318.

Pharmedium Services

Class I - Dangerous

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Jul 17, 2015 Prescription Drugs Nationwide View Details →