DrugApr 10, 2019
KRS Global Biotechnology NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / recall — FDA D-1079-2019
Labeling: Label mix-up
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
10,690drug recall records
953FDA Class I records
8firms with 5+ records
Aidapak Services, LLC537 records
Database records
Records — page 184
10,690 detailed records are currently available in this category.
DrugApr 10, 2019
Pfizer Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial recall — FDA D-1072-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class IIIFDA: TerminatedPfizer Inc.
DrugApr 10, 2019
Pfizer Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials recall — FDA D-1070-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class IIIFDA: TerminatedPfizer Inc.
DrugApr 10, 2019
Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial recall — FDA D-1068-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class IIIFDA: TerminatedPfizer Inc.
DrugApr 10, 2019
Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial recall — FDA D-1067-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class IIIFDA: TerminatedPfizer Inc.
DrugApr 10, 2019
Pacific Compounding Pharmacy & Consultations Cefuroxime 10mg/mL INJ 0.5 mg, SDV recall — FDA D-1076-2019
Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the…
Class IIFDA: TerminatedPacific Compounding Pharmacy & Consultations Inc.
DrugApr 3, 2019
Ecolab Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab recall — FDA D-1064-2019
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class IIFDA: TerminatedEcolab Inc.
DrugApr 3, 2019
ECOLAB Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles recall — FDA D-1062-2019
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class IIFDA: TerminatedEcolab Inc.
DrugApr 3, 2019
Advanced Gel Hand Sanitizer (Ethyl alcohol 62%) recall — FDA D-1061-2019
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class IIFDA: TerminatedEcolab Inc.
DrugApr 3, 2019
Lupin Pharmaceuticals Fayosim recall — FDA D-1057-2019
Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol…
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugApr 3, 2019
Ecolab Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles recall — FDA D-1063-2019
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class IIFDA: TerminatedEcolab Inc.
DrugApr 3, 2019
Ata International Blue Fusion Capsules, 1- count blister pack recall — FDA D-1085-2019
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil,…
Class IFDA: TerminatedAta International Inc.
DrugApr 3, 2019
Ingenus Pharmaceuticals Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL recall — FDA D-1058-2019
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Class IIIFDA: TerminatedIngenus Pharmaceuticals LLC
DrugApr 3, 2019
ECOLAB Gel Hand Sanitizer (Ethyl Alcohol 70%) recall — FDA D-1060-2019
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class IIFDA: TerminatedEcolab Inc.
DrugMar 27, 2019
Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles recall — FDA D-1010-2019
Defective Container: Repetitive complaints received indicating pump not working.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugMar 27, 2019
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe recall — FDA D-1008-2019
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Class IIFDA: TerminatedIso-Tex Diagnostics, Inc.
DrugMar 27, 2019
Advanced Pharma Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate recall — FDA D-1033-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugMar 27, 2019
Losartan Potassium Tablets USP, 50 mg recall — FDA D-1042-2019
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Class IIFDA: OngoingCamber Pharmaceuticals Inc.
DrugMar 27, 2019
Advanced Pharma Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable recall — FDA D-1023-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugMar 27, 2019
Rx Pak Division of McKesson Docusate Sodium, 100mg softgels recall — FDA D-1007-2019
Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
Class IIFDA: TerminatedRx Pak Division of McKesson Corporation
DrugMar 27, 2019
Losartan Potassium Tablets USP, 100 mg recall — FDA D-1043-2019
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Class IIFDA: OngoingCamber Pharmaceuticals Inc.
DrugMar 27, 2019
American Health Packaging Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose recall — FDA D-1047-2019
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Class IIFDA: TerminatedAmerican Health Packaging
DrugMar 27, 2019
Losartan Potassium Tablets USP, 25 mg recall — FDA D-1041-2019
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Class IIFDA: OngoingCamber Pharmaceuticals Inc.
DrugMar 27, 2019
Advanced Pharma Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable recall — FDA D-1022-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedAdvanced Pharma Inc.
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.