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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 13901–13920 of 17,832 recalls

Class IITerminated

Aztreonam 1 gram in normal saline

Walgreens Infusion Services

Lack of sterility assurance.

December 26, 2014 · DrugView details →

Class IITerminated

Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-6046-48, Product Code 2J1446.

Baxter Healthcare Corp.

Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.

December 23, 2014 · DrugView details →

Class IITerminated

Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30

Hospira Inc.

Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.

December 23, 2014 · DrugView details →

Class IITerminated

Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; 100-bottle capsules - NDC 68382-247-01 500-bottle capsules - NDC 68382-247-05

Zydus Pharmaceuticals USA Inc

Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.

December 23, 2014 · DrugView details →

Class IITerminated

0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7984-11

Hospira Inc.

Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port.

December 22, 2014 · DrugView details →

Class IIITerminated

ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811

Qualitest Pharmaceuticals

Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.

December 22, 2014 · DrugView details →

Class ITerminated

SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc.

Bethel Nutritional Consulting, Inc

Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.

December 19, 2014 · DrugView details →

Class IIITerminated

3M ESPE Clinpro 5000 (1.1% Sodium Flouride), Anti-Cavity Toothpaste, 4 oz tube (NDC 48878-3130-04), Rx Only, Manufactured for 3M ESPE Dental Products, St. Paul, MN 55144

3M Company/3m Espe Dental Products

Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..

December 19, 2014 · DrugView details →

Class IITerminated

B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional Consulting, Inc.599 West 190th Street, Suite #1 NYC, NY 10040.

Bethel Nutritional Consulting, Inc

Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss

December 19, 2014 · DrugView details →

Class ITerminated

Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46mEq/mL, 600 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

Central Admixture Pharmacy Services, Inc.

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

December 17, 2014 · DrugView details →

Class ITerminated

Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acids, Neonate 3g, Dextrose 5%, 150 ml, Additives: heparin PF 75 units, Calcium Gluconate 300mg, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

Central Admixture Pharmacy Services, Inc.

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

December 17, 2014 · DrugView details →

Class ITerminated

Rose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

Central Admixture Pharmacy Services, Inc.

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

December 17, 2014 · DrugView details →

Class ITerminated

Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag with Calcium, Trophamine 5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46 mEq/mL, 750mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

Central Admixture Pharmacy Services, Inc.

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

December 17, 2014 · DrugView details →

Class ITerminated

Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 10%, Additives: heparin PF 1 unit(s)/ml, Calcium Gluconate 2.3mEq/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

Central Admixture Pharmacy Services, Inc.

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

December 17, 2014 · DrugView details →

Class ITerminated

Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 4%Dex5% ,Trophamine 4% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

Central Admixture Pharmacy Services, Inc.

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

December 17, 2014 · DrugView details →

Class ITerminated

Methodist Hospital Northlake (IN) Neo Starter TPN D5, AA2, Trophamine 2% Dextrose 5%, Additives: heparin PF 100 units/mL, 50 units/dL, Calcium Gluconate 0.46 mEq/mL, 200 mg/dL, compound vol: 300 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

Central Admixture Pharmacy Services, Inc.

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

December 17, 2014 · DrugView details →

Class ITerminated

Virtua West Jersey Voorhees (NJ) TPN Neonatal Starter Bag, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 200mg/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

Central Admixture Pharmacy Services, Inc.

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

December 17, 2014 · DrugView details →

Class ITerminated

Truman Medical Center Lakewood (MO) Starter TPN, Trophamine 5.25g, Dextrose 10%, Additives: Calcium Gluconate 4.8mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

Central Admixture Pharmacy Services, Inc.

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

December 17, 2014 · DrugView details →

Class ITerminated

Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, Additives: Calcium Gluconate 1500 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

Central Admixture Pharmacy Services, Inc.

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

December 17, 2014 · DrugView details →

Class ITerminated

Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag, Trophamine 5 gm , Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

Central Admixture Pharmacy Services, Inc.

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

December 17, 2014 · DrugView details →

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