DrugFeb 3, 2016
Sentara Enterprises MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in recall — FDA D-0611-2016
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class IIFDA: TerminatedSentara Enterprises
10,690drug recall records
953FDA Class I records
8firms with 5+ records
Aidapak Services, LLC537 records
Database records
Records — page 275
10,690 detailed records are currently available in this category.
DrugFeb 3, 2016
Sentara Enterprises CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps recall — FDA D-0629-2016
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class IIFDA: TerminatedSentara Enterprises
DrugFeb 3, 2016
Sentara Enterprises POTASSIUM CHLORIDE in D 5 1/2NS recall — FDA D-0619-2016
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class IIFDA: TerminatedSentara Enterprises
DrugFeb 3, 2016
Sentara Enterprises CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes recall — FDA D-0612-2016
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class IIFDA: TerminatedSentara Enterprises
DrugFeb 3, 2016
Sentara Enterprises CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML recall — FDA D-0621-2016
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class IIFDA: TerminatedSentara Enterprises
DrugJan 27, 2016
Freedom Pharmaceuticals Baclofen USP powder recall — FDA D-0573-2016
Presence of Foreign Substance
Class IIFDA: TerminatedFreedom Pharmaceuticals Inc.
DrugJan 27, 2016
Pine Pharmaceuticals Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for recall — FDA D-0581-2016
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Class IIFDA: TerminatedPine Pharmaceuticals, LLC
DrugJan 27, 2016
Grato Holdings Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical recall — FDA D-0575-2016
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class IIFDA: TerminatedGrato Holdings, Inc.
DrugJan 27, 2016
Mutual Pharmaceutical Company Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg recall — FDA D-0572-2016
Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
Class IIFDA: TerminatedMutual Pharmaceutical Company, Inc.
DrugJan 27, 2016
Pine Pharmaceuticals Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16" Syringe for recall — FDA D-0583-2016
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Class IIFDA: TerminatedPine Pharmaceuticals, LLC
DrugJan 27, 2016
Grato Holdings Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical recall — FDA D-0576-2016
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class IIFDA: TerminatedGrato Holdings, Inc.
DrugJan 27, 2016
Grato Holdings Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical recall — FDA D-0578-2016
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class IIFDA: TerminatedGrato Holdings, Inc.
DrugJan 27, 2016
Grato Holdings Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical recall — FDA D-0579-2016
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class IIFDA: TerminatedGrato Holdings, Inc.
DrugJan 27, 2016
Pine Pharmaceuticals Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for recall — FDA D-0584-2016
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Class IIFDA: TerminatedPine Pharmaceuticals, LLC
DrugJan 27, 2016
Pine Pharmaceuticals Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" recall — FDA D-0582-2016
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Class IIFDA: TerminatedPine Pharmaceuticals, LLC
DrugJan 27, 2016
Grato Holdings Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz recall — FDA D-0580-2016
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class IIFDA: TerminatedGrato Holdings, Inc.
DrugJan 27, 2016
Grato Holdings Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray recall — FDA D-0577-2016
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class IIFDA: TerminatedGrato Holdings, Inc.
DrugJan 27, 2016
Phentermine Hydrochloride Capsules, USP, 15 mg recall — FDA D-0574-2016
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Class IIIFDA: TerminatedPD-Rx Pharmaceuticals, Inc.
DrugJan 20, 2016
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND recall — FDA D-0566-2016
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugJan 20, 2016
National Vitamin Co Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 recall — FDA D-0568-2016
Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
Class IIIFDA: TerminatedNational Vitamin Co Inc.
DrugJan 20, 2016
Freedom Pharmaceuticals Domperidone BP, Active Pharmaceutical Ingredient for Prescription recall — FDA D-0567-2016
Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.
Class IIFDA: TerminatedFreedom Pharmaceuticals Inc.
DrugJan 13, 2016
Freedom Pharmaceuticals 5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC recall — FDA D-0562-2016
Subpotent Drug
Class IIIFDA: TerminatedFreedom Pharmaceuticals Inc.
DrugJan 13, 2016
PD-Rx Pharmaceuticals Azithromycin Tablets, USP, 250 mg recall — FDA D-0560-2016
cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
Class IIFDA: TerminatedPD-Rx Pharmaceuticals, Inc.
DrugJan 13, 2016
Avantor Performance Materials Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR recall — FDA D-0563-2016
Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
Class IIIFDA: TerminatedAvantor Performance Materials 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.