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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 13021–13040 of 17,816 recalls

Class IIITerminated

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 Corp

CGMP Deviation: Poor container closure of the bulk storage container

June 5, 2015 · DrugView details →

Class IITerminated

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, LLC

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

June 4, 2015 · DrugView details →

Class IIITerminated

Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of minor aches and pains of muscles and joints, a) 2 oz. Tube, NDC 10578-035-05, b) 5 oz. Jar, NDC 10578-035-04, Manufactured by Indiana Botanic Gardens, Hobart, IN 46342

Indiana Botanic Gardens, Inc

Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.

June 4, 2015 · DrugView details →

Class IIITerminated

Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box, 28 Tablets Each, Rx Only, Manufactured for: Watson Pharm, Inc., a subsidiary of Watson Pharmaceutical, Inc., Corona, CA 92880, Manufactured by: Patheon, Inc., Mississauga, Ontario L9N7K9 Canada, NDC 52544-0949-28

Actavis Inc

Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.

June 4, 2015 · DrugView details →

Class IITerminated

Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03

Baxter Healthcare Corp

Subpotent Drug; out of specification results for heparin raw material

June 3, 2015 · DrugView details →

Class ITerminated

Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011

Centro Naturista

Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.

June 3, 2015 · DrugView details →

Class ITerminated

Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011

Centro Naturista

Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.

June 3, 2015 · DrugView details →

Class IITerminated

HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

June 2, 2015 · DrugView details →

Class IITerminated

Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

June 2, 2015 · DrugView details →

Class IITerminated

HCG 1,250 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

June 2, 2015 · DrugView details →

Class IITerminated

Hydromorphone 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

June 2, 2015 · DrugView details →

Class IITerminated

Morphine 60 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

June 2, 2015 · DrugView details →

Class IITerminated

Hyaluronic Acid Sodium 28 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

June 2, 2015 · DrugView details →

Class IITerminated

Hydromorphone 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

June 2, 2015 · DrugView details →

Class IITerminated

Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

June 2, 2015 · DrugView details →

Class IITerminated

Fentanyl 2,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

June 2, 2015 · DrugView details →

Class IITerminated

Morphine 25 mg/ml + Bupivacaine 30 mg/ml + Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

June 2, 2015 · DrugView details →

Class IITerminated

Testosterone 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

June 2, 2015 · DrugView details →

Class IITerminated

Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml + Baclofen 750 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

June 2, 2015 · DrugView details →

Class IITerminated

Tri-Mix AT-6 (60 mg/4 mg/0.3 mg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

June 2, 2015 · DrugView details →

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