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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 16761–16780 of 17,860 recalls

Class IITerminated

Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12

Hospira Inc.

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

May 16, 2013 · DrugView details →

Class IITerminated

Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132

Pentec Health

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

May 15, 2013 · DrugView details →

Class IITerminated

Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132

Pentec Health

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

May 15, 2013 · DrugView details →

Class IITerminated

Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132

Pentec Health

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

May 15, 2013 · DrugView details →

Class IIITerminated

Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr 10mg , Phenylephrine HCL 5mg, a) 8 coated caplets (NDC 0067-6437-08) b) 24 coated caplets (NDC 0067-6438-24). Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622.

Novartis Consumer Health

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

May 15, 2013 · DrugView details →

Class IIITerminated

Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula and 16 coated caplets nighttime formula *includes antihistamine Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2082-32.

Novartis Consumer Health

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

May 15, 2013 · DrugView details →

Class IITerminated

Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and c) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132

Pentec Health

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

May 15, 2013 · DrugView details →

Class IITerminated

Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

Pentec Health

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

May 15, 2013 · DrugView details →

Class IITerminated

Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids and KCL), in 3000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132

Pentec Health

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

May 15, 2013 · DrugView details →

Class IITerminated

Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), 1000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132

Pentec Health

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions

May 15, 2013 · DrugView details →

Class IITerminated

Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 805mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

Pentec Health

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

May 15, 2013 · DrugView details →

Class IITerminated

Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132

Pentec Health

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

May 15, 2013 · DrugView details →

Class IITerminated

Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

Pentec Health

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

May 15, 2013 · DrugView details →

Class IITerminated

Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

Pentec Health

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions

May 15, 2013 · DrugView details →

Class IITerminated

Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

Pentec Health

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

May 15, 2013 · DrugView details →

Class IIITerminated

Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.

Novartis Consumer Health

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

May 15, 2013 · DrugView details →

Class IITerminated

IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132

Pentec Health

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

May 15, 2013 · DrugView details →

Class IIITerminated

Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) b) 24 coated caplets (NDC 0067-6438-24), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622.

Novartis Consumer Health

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

May 15, 2013 · DrugView details →

Class IITerminated

HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for: Health & Beyond 7050 W Palmetto Pk Rd Boca Raton, FL 33433.

Health & Beyond

Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic)

May 15, 2013 · DrugView details →

Class IIITerminated

Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed by: UDL Laboratories, Inc., Rockford, IL 61103, NDC 51079-020-03.

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.

May 15, 2013 · DrugView details →

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