DrugJul 15, 2015
American Health Packaging Azithromycin tablets, USP 600mg recall — FDA D-1222-2015
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class IIFDA: TerminatedAmerican Health Packaging
July 2015 recalls — page 6
These records include useful source details for the selected month.
DrugJul 15, 2015
Apotex Losartan potassium tablets USP, 50 mg, 90-count bottle recall — FDA D-1214-2015
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Class IIFDA: TerminatedApotex Inc.
DrugJul 15, 2015
American Health Packaging Lisinopril tablets, USP 10mg recall — FDA D-1227-2015
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class IIFDA: TerminatedAmerican Health Packaging
DrugJul 15, 2015
Abrams Royal Pharmacy II CORTISOL-MC, 10mg CAP recall — FDA D-1231-2015
Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.
Class IIIFDA: TerminatedAbrams Royal Pharmacy II, LLC
DrugJul 15, 2015
BioComp Pharma Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from recall — FDA D-1233-2015
Subpotent Drug: menthol and methyl salicylate below specification
Class IIIFDA: TerminatedBioComp Pharma, Inc.
DrugJul 15, 2015
DEXTROSE 10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags recall — FDA D-1210-2015
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Class IFDA: TerminatedBaxter Healthcare Corp.
DrugJul 15, 2015
Apotex Losartan potassium tablets USP, 100 mg, 90-count bottle recall — FDA D-1213-2015
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Class IIFDA: TerminatedApotex Inc.
DrugJul 15, 2015
Teva Pharmaceuticals USA Adrucil recall — FDA D-1089-2015
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Class IFDA: TerminatedTeva Pharmaceuticals USA
DrugJul 15, 2015
Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags recall — FDA D-1211-2015
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Class IFDA: TerminatedBaxter Healthcare Corp.
DrugJul 15, 2015
DEXTROSE 5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags recall — FDA D-1209-2015
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Class IFDA: TerminatedBaxter Healthcare Corp.
DrugJul 15, 2015
Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use recall — FDA D-1216-2015
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Class IFDA: TerminatedHospira Inc.
DrugJul 15, 2015
American Health Packaging Amlodipine besylate tablets, USP 5mg recall — FDA D-1219-2015
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class IIFDA: TerminatedAmerican Health Packaging
DrugJul 15, 2015
American Health Packaging Lisinopril tablets, USP 20mg recall — FDA D-1228-2015
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class IIFDA: TerminatedAmerican Health Packaging
DrugJul 15, 2015
American Health Packaging Famotidine tablets, USP 20mg recall — FDA D-1225-2015
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class IIFDA: TerminatedAmerican Health Packaging
DrugJul 15, 2015
American Health Packaging Amlodipine besylate tablets, USP 10 mg recall — FDA D-1220-2015
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class IIFDA: TerminatedAmerican Health Packaging
DrugJul 15, 2015
SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags recall — FDA D-1208-2015
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Class IFDA: TerminatedBaxter Healthcare Corp.
DrugJul 15, 2015
American Health Packaging Azithromycin tablets, USP 250mg recall — FDA D-1223-2015
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class IIFDA: TerminatedAmerican Health Packaging
DrugJul 15, 2015
American Health Packaging Lisinopril tablets, USP 40mg recall — FDA D-1229-2015
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class IIFDA: TerminatedAmerican Health Packaging
DrugJul 15, 2015
Hospira Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM recall — FDA D-1232-2015
Failed pH Specifications: 12 month stability testing
Class IIIFDA: TerminatedHospira Inc.
DrugJul 15, 2015
American Health Packaging Lisinopril tablets, USP 5mg recall — FDA D-1226-2015
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class IIFDA: TerminatedAmerican Health Packaging
DrugJul 15, 2015
American Health Packaging Azithromycin tablets, USP 500mg recall — FDA D-1221-2015
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class IIFDA: TerminatedAmerican Health Packaging
DrugJul 15, 2015
Apotex Losartan potassium tablets USP, 25 mg, 90- count bottle recall — FDA D-1212-2015
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Class IIFDA: TerminatedApotex Inc.
DrugJul 15, 2015
American Health Packaging Zonisamide capsules, USP 100mg recall — FDA D-1230-2015
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class IIFDA: TerminatedAmerican Health Packaging
DrugJul 15, 2015
American Health Packaging Amlodipine besylate tablets, USP 2.5mg recall — FDA D-1218-2015
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class IIFDA: TerminatedAmerican Health Packaging
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.