DrugJun 22, 2016
Nostrum Laboratories Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY recall — FDA D-1030-2016
Failed Dissolution Specifications
Class IIFDA: TerminatedNostrum Laboratories, Inc.
10,690drug recall records
953FDA Class I records
8firms with 5+ records
Aidapak Services, LLC537 records
Database records
Records — page 268
10,690 detailed records are currently available in this category.
DrugJun 22, 2016
Par Pharmaceutical Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg recall — FDA D-1038-2016
Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above…
Class IIIFDA: TerminatedPar Pharmaceutical
DrugJun 15, 2016
SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag recall — FDA D-0957-2016
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Class IFDA: TerminatedBaxter Healthcare Corp.
DrugJun 15, 2016
Novacare Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra recall — FDA D-0963-2016
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Class IFDA: TerminatedNovacare, LLC
DrugJun 15, 2016
Novacare Thin and Slim Naturally The Natural Alternative AM Dietary Supplement recall — FDA D-0968-2016
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Class IFDA: TerminatedNovacare, LLC
DrugJun 15, 2016
Novacare Thin and Slim Extreme Stack Fat Burner Dietary Supplement recall — FDA D-0969-2016
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Class IFDA: TerminatedNovacare, LLC
DrugJun 15, 2016
Novacare The Store Thin and Slim Thermogenic Fat Burner Dietary Supplement recall — FDA D-0966-2016
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Class IFDA: TerminatedNovacare, LLC
DrugJun 15, 2016
Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not recall — FDA D-0958-2016
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Class IFDA: TerminatedBaxter Healthcare Corp.
DrugJun 15, 2016
Reesna FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle recall — FDA D-0959-2016
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of…
Class IFDA: TerminatedReesna, Inc.
DrugJun 15, 2016
Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen recall — FDA D-0956-2016
Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step
Class IIFDA: TerminatedNovo Nordisk Inc.
DrugJun 15, 2016
Pharmedium Services Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag recall — FDA D-0976-2016
Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.
Class IIFDA: TerminatedPharmedium Services, LLC
DrugJun 15, 2016
Reesna FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count recall — FDA D-0960-2016
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of…
Class IFDA: TerminatedReesna, Inc.
DrugJun 8, 2016
Lupin Pharmaceuticals Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) recall — FDA D-0954-2016
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJun 8, 2016
Lupin Pharmaceuticals Ceftriaxone for Injection USP, 500 mg, Single Use Vial recall — FDA D-0952-2016
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJun 8, 2016
Lupin Pharmaceuticals Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) recall — FDA D-0953-2016
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJun 8, 2016
Lupin Pharmaceuticals Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF recall — FDA D-0955-2016
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJun 8, 2016
Lupin Pharmaceuticals Ceftriaxone for Injection USP, 250 mg, Single Use Vial recall — FDA D-0951-2016
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJun 8, 2016
Taro Pharmaceuticals U.S.A ¿Topicort (desoximetasone) Cream USP, 0.05% recall — FDA D-0950-2016
Subpotent Drug
Class IIIFDA: TerminatedTaro Pharmaceuticals U.S.A., Inc.
DrugJun 1, 2016
Akorn Chlorhexidine gluconate, oral rinse, 0.12% recall — FDA D-0875-2016
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Class IIFDA: TerminatedAkorn, Inc.
DrugJun 1, 2016
Teva Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31) recall — FDA D-0868-2016
Lack of Assurance of Sterility: Due to potential for leaking bags.
Class IIFDA: TerminatedTeva North America
DrugJun 1, 2016
Akorn PerioRx (chlorhexidine gluconate), oral rinse, 0.12% recall — FDA D-0876-2016
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Class IIFDA: TerminatedAkorn, Inc.
DrugJun 1, 2016
Teva Pharmaceuticals USA Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial recall — FDA D-0859-2016
Presence of Particulate Matter: particulate matter identified as glass in one vial.
Class IFDA: TerminatedTeva Pharmaceuticals USA
DrugJun 1, 2016
Sanofi-Aventis U.S Auvi-Q recall — FDA D-0872-2016
Defective Delivery System; potential to have inaccurate dosage delivery
Class IFDA: TerminatedSanofi-Aventis U.S. LLC
DrugJun 1, 2016
SUPER HERBS 350 mg, 30 capsules per bottle recall — FDA D-0909-2016
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein.
Class IFDA: TerminatedSuper Herbs
How to use this drug recall index
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.