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Prescription Drugs

💊 Drugs • 12,141 recalls

BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center, Suite 400, Princeton, NJ 08805, NDC: 63739-706-10

Mckesson Packaging Services

Class I - Dangerous

Failed Moisture Limits: Product tested out-of-specification for moisture content.

May 30, 2017 Prescription Drugs Nationwide View Details →

Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8

Noven Pharmaceuticals

Class I - Dangerous

Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.

Apr 27, 2017 Prescription Drugs Nationwide View Details →

Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4), b) 100 g packaged in 16 oz container (NDC: 58597-8082-6), c) 500 g packaged in a 2500 cc container (NDC: 58597-8082-7) and a 1,000 g packaged in 1 gallon container (NDC: 58597-8082-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

American Pharmaceutical Ingredients

Class I - Dangerous

Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.

Jun 1, 2017 Prescription Drugs Nationwide View Details →

Venlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg, packaged in a) 30-count bottles (NDC 52343-132-30) and b) 90-count bottles (NDC 52343-132-90), Rx only, Distributed by: Lucid Pharma LLC, 2 Tower Center Blvd, Suite-1101-B, East Brunswick, NJ 08816 USA.

Lucid Pharma

Class I - Dangerous

Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules.

Jun 1, 2017 Prescription Drugs Nationwide View Details →

Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04

Hospira Inc., A Pfizer Company

Class I - Dangerous

GMP Deviation; A foreign stopper was observed during packaging of a lot of product.

May 18, 2017 Prescription Drugs Nationwide View Details →

Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904323392.

Safecor Health

Class I - Dangerous

CGMP Deviations

Jul 7, 2016 Prescription Drugs View Details →

Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Code 2K5284, NDC# 61553-0284-48, Total Volume 100.00 mL incorrectly labeled as 102.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

Pharmedium Services

Class I - Dangerous

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Feb 17, 2017 Prescription Drugs Nationwide View Details →

VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227, NDC# 61553-027-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

Pharmedium Services

Class I - Dangerous

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Feb 17, 2017 Prescription Drugs Nationwide View Details →

Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service Code 2K5298, NDC# 61553-0298-48, Total Volume 100.00 mL incorrectly labeled as 102.50 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

Pharmedium Services

Class I - Dangerous

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Feb 17, 2017 Prescription Drugs Nationwide View Details →

Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014

Complete Pharmacy and Medical Solutions

Class I - Dangerous

Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.

Dec 29, 2015 Prescription Drugs View Details →

Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904198280.

Safecor Health

Class I - Dangerous

CGMP Deviations

Jul 7, 2016 Prescription Drugs View Details →

VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2237, NDC# 61553-037-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

Pharmedium Services

Class I - Dangerous

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Feb 17, 2017 Prescription Drugs Nationwide View Details →

ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327

American Pharmaceutical Ingredients

Class I - Dangerous

cGMP Deviations; lack of quality assurance.

Apr 17, 2017 Prescription Drugs View Details →

Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014

Complete Pharmacy and Medical Solutions

Class I - Dangerous

Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.

Apr 2, 2016 Prescription Drugs Nationwide View Details →

Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141

Pharmedium Services

Class I - Dangerous

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Feb 17, 2017 Prescription Drugs Nationwide View Details →

Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code 2K5288, NDC# 61553-0288-48, Total Volume 100.00 mL incorrectly labeled as 103.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

Pharmedium Services

Class I - Dangerous

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Feb 17, 2017 Prescription Drugs Nationwide View Details →

Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code 2K5856, NDC# 61553-0856-48, Total Volume 100.00 mL incorrectly labeled as 105.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141

Pharmedium Services

Class I - Dangerous

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Feb 17, 2017 Prescription Drugs Nationwide View Details →

Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, NDC# 61553-0299-48, Total Volume 100.00 mL incorrectly labeled as 150.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

Pharmedium Services

Class I - Dangerous

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Feb 17, 2017 Prescription Drugs Nationwide View Details →

Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Service Code 2K5295, NDC# 61553-0295-48, Total Volume 100.00 mL incorrectly labeled as105.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

Pharmedium Services

Class I - Dangerous

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Feb 17, 2017 Prescription Drugs Nationwide View Details →

Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93

Mylan Pharmaceuticals

Class I - Dangerous

Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities

May 9, 2017 Prescription Drugs Nationwide View Details →

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