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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 8301–8320 of 17,773 recalls

Class IITerminated

Man Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0025-1 and Tester NDC 61096-1025-1

Sprayology

CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

October 9, 2018 · DrugView details →

Class IITerminated

Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0032-1

Sprayology

CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

October 9, 2018 · DrugView details →

Class IITerminated

Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0012-1 and Tester NDC 61096-1012-1

Sprayology

CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

October 9, 2018 · DrugView details →

Class IITerminated

0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045

ICU Medical Inc

Lack of Assurance of Sterility; bags have the potential to leak

October 8, 2018 · DrugView details →

Class IITerminated

5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045

ICU Medical Inc

Lack of Assurance of Sterility; bags have the potential to leak

October 8, 2018 · DrugView details →

Class IITerminated

Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10

Akorn, Inc.

Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.

October 8, 2018 · DrugView details →

Class IITerminated

Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60

LUPIN SOMERSET

Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis

October 5, 2018 · DrugView details →

Class IIITerminated

Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.

Amerigen Pharmaceuticals Inc.

Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.

October 5, 2018 · DrugView details →

Class IIITerminated

Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-count bottles, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99

Orexigen Therapeutics, Inc.

Container packaging defect.

October 5, 2018 · DrugView details →

Class ITerminated

Native Remedies VaricoGo Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-105-59

Silver Star Brands

Microbial Contamination of Non-Sterile Products

October 3, 2018 · DrugView details →

Class IIITerminated

Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159, NDC 69097-128-15

InvaGen Pharmaceuticals, Inc.

Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.

October 3, 2018 · DrugView details →

Class ITerminated

Native Remedies HypoSlim Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-275-02

Silver Star Brands

Microbial Contamination of Non-Sterile Products

October 3, 2018 · DrugView details →

Class ITerminated

Native Remedies EyeClear Pro Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-151-59

Silver Star Brands

Microbial Contamination of Non-Sterile Product

October 3, 2018 · DrugView details →

Class IITerminated

Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-204-02

Silver Star Brands

CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

October 3, 2018 · DrugView details →

Class IITerminated

Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g Total, 500 mL Single-Dose Container bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-6729-03.

Pfizer Inc.

Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection.

October 3, 2018 · DrugView details →

Class IITerminated

Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906 NDC 68703-206-02

Silver Star Brands

CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

October 3, 2018 · DrugView details →

Class ITerminated

Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-253-02

Silver Star Brands

Microbial Contamination of Non-Sterile Products

October 3, 2018 · DrugView details →

Class IITerminated

Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.

Jubilant Cadista Pharmaceuticals, Inc.

Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.

October 2, 2018 · DrugView details →

Class IITerminated

Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, KY 40356

Tailor Made Compounding

Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date

September 28, 2018 · DrugView details →

Class IITerminated

Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing

September 27, 2018 · DrugView details →

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