DrugJun 14, 2017
Qualgen Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 recall — FDA D-0890-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
10,690drug recall records
953FDA Class I records
8firms with 5+ records
Aidapak Services, LLC537 records
Database records
Records — page 240
10,690 detailed records are currently available in this category.
DrugJun 14, 2017
Qualgen Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 recall — FDA D-0892-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
DrugJun 14, 2017
Qualgen Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 recall — FDA D-0889-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
DrugJun 14, 2017
Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count recall — FDA D-0883-2017
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class IIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugJun 14, 2017
Acyclovir Tablets, USP, 800 mg, 100-count bottle recall — FDA D-0897-2017
Presence of Foreign Substance: human hair melded into tablet.
Class IIIFDA: TerminatedHetero USA Inc.
DrugJun 14, 2017
Qualgen Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count recall — FDA D-0896-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
DrugJun 14, 2017
Spectrum Laboratory Products Levonorgestrel, U.S.P. active pharmaceutical ingredient recall — FDA D-0882-2017
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current…
Class IIFDA: TerminatedSpectrum Laboratory Products, Inc.
DrugJun 14, 2017
Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count recall — FDA D-0885-2017
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class IIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugJun 14, 2017
Qualgen Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 recall — FDA D-0893-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
DrugJun 14, 2017
Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count recall — FDA D-0886-2017
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class IIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugJun 7, 2017
SCA Pharmaceuticals ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g recall — FDA D-0876-2017
Lack of assurance of sterility: Product bags leaking at seam.
Class IIFDA: TerminatedSCA Pharmaceuticals
DrugJun 7, 2017
SCA Pharmaceuticals HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml recall — FDA D-0875-2017
Lack of assurance of sterility: Product bags leaking at seam.
Class IIFDA: TerminatedSCA Pharmaceuticals
DrugJun 7, 2017
SCA Pharmaceuticals morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total recall — FDA D-0871-2017
Lack of assurance of sterility: Product bags leaking at seam.
Class IIFDA: TerminatedSCA Pharmaceuticals
DrugJun 7, 2017
SCA Pharmaceuticals fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL recall — FDA D-0873-2017
Lack of assurance of sterility: Product bags leaking at seam.
Class IIFDA: TerminatedSCA Pharmaceuticals
DrugJun 7, 2017
VistaPharm Nystatin Oral Suspension, USP, 100,000 units/mL recall — FDA D-0869-2017
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Class IIIFDA: TerminatedVistaPharm, Inc.
DrugJun 7, 2017
SCA Pharmaceuticals MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g recall — FDA D-0878-2017
Lack of assurance of sterility: Product bags leaking at seam.
Class IIFDA: TerminatedSCA Pharmaceuticals
DrugJun 7, 2017
SCA Pharmaceuticals fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL recall — FDA D-0872-2017
Lack of assurance of sterility: Product bags leaking at seam.
Class IIFDA: TerminatedSCA Pharmaceuticals
DrugJun 7, 2017
SCA Pharmaceuticals morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total recall — FDA D-0870-2017
Lack of assurance of sterility: Product bags leaking at seam.
Class IIFDA: TerminatedSCA Pharmaceuticals
DrugJun 7, 2017
SCA Pharmaceuticals ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g recall — FDA D-0877-2017
Lack of assurance of sterility: Product bags leaking at seam.
Class IIFDA: TerminatedSCA Pharmaceuticals
DrugJun 7, 2017
SCA Pharmaceuticals PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg recall — FDA D-0879-2017
Lack of assurance of sterility: Product bags leaking at seam.
Class IIFDA: TerminatedSCA Pharmaceuticals
DrugJun 7, 2017
Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs recall — FDA D-0880-2017
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Class IIFDA: TerminatedForest Laboratories, LLC
DrugJun 7, 2017
SCA Pharmaceuticals fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg recall — FDA D-0874-2017
Lack of assurance of sterility: Product bags leaking at seam.
Class IIFDA: TerminatedSCA Pharmaceuticals
DrugMay 31, 2017
Fagron Estrone, For Prescription Compounding recall — FDA D-0792-2017
cGMP Deviations: lack of quality assurance at the API manufacturer.
Class IIFDA: TerminatedFagron, Inc.
DrugMay 31, 2017
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack recall — FDA D-0861-2017
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the…
Class IIIFDA: TerminatedMylan Pharmaceuticals 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.