January 9, 2019DrugsFDA
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy recalls Lidocaine gel 1%, RX, plastic dropper
Hazard: Lack of sterility assurance.
January 9, 2019DrugsFDA
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy recalls Glutathione liquid, 200mg/ml, Rx
Hazard: Lack of sterility assurance.
January 9, 2019DrugsFDA
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy recalls Cyclosporin liquid 0.05%, Rx, plastic dropper bottle
Hazard: Lack of sterility assurance.
January 9, 2019DrugsFDA
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy recalls Cyclosporin liquid 0.2%, Rx, plastic dropper bottle
Hazard: Lack of sterility assurance.
January 9, 2019DrugsFDA
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy recalls Cyclosporin liquid 0.5%, Rx, plastic dropper bottle
Hazard: Lack of sterility assurance.
January 9, 2019DrugsFDA
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy recalls Cyclosporin liquid 1%, Rx, plastic dropper bottle
Hazard: Lack of sterility assurance.
January 9, 2019DrugsFDA
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy recalls Vitamin B12 liquid 1000mcg/ml, RX, glass vial
Hazard: Lack of sterility assurance.
January 9, 2019DrugsFDA
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy recalls Testosteron Cypionate liquid 200mg/ml, RX, glass vial
Hazard: Lack of sterility assurance.
January 9, 2019DrugsFDA
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy recalls Methocarbamol liquid 100mg/ml, RX, glass vial
Hazard: Lack of sterility assurance.
January 9, 2019DrugsFDA
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy recalls MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial
Hazard: Lack of sterility assurance.
January 9, 2019DrugsFDA
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy recalls Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye
Hazard: Lack of sterility assurance.
January 9, 2019DrugsFDA
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy recalls Lidocaine gel 2%, RX, plastic dropper
Hazard: Lack of sterility assurance.
January 9, 2019DrugsFDA
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy recalls Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial
Hazard: Lack of sterility assurance.
January 9, 2019DrugsFDA
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy recalls HCG liquid, 1000u/ml, RX, glass vial, various
Hazard: Lack of sterility assurance.
January 9, 2019DrugsFDA
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy recalls Glutathione liquid, 100mg/ml
Hazard: Lack of sterility assurance.
January 9, 2019DrugsFDA
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy recalls Epinephrine liquid 1:1000, RX, glass vial
Hazard: Lack of sterility assurance.
January 9, 2019DrugsFDA
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy recalls Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye
Hazard: Lack of sterility assurance.
January 9, 2019DrugsFDA
LUPIN SOMERSET recalls Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somers
Hazard: Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
January 2, 2019DrugsFDA
Advanced Pharma Inc. recalls Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (
Hazard: Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
January 2, 2019DrugsFDA
Amerigen Pharmaceuticals Inc. recalls Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, C
Hazard: Failed Dissolution Specifications
January 2, 2019DrugsFDA
Amerigen Pharmaceuticals Inc. recalls Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx
Hazard: Failed Dissolution Specifications
December 26, 2018DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar P
Hazard: Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
December 26, 2018DrugsFDA
Cipla Limited recalls Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Man
Hazard: Failed Dissolution Specifications.
December 26, 2018DrugsFDA
Results RNA, LLC recalls Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed
Hazard: Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
December 26, 2018DrugsFDA
Asclemed USA Inc. dba Enovachem recalls Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501,
Hazard: Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex
December 26, 2018DrugsFDA
Asclemed USA Inc. dba Enovachem recalls Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501,
Hazard: Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex
December 26, 2018DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceutica
Hazard: Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
December 26, 2018DrugsFDA
VistaPharm, Inc. recalls NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose
Hazard: Failed Impurities/Degradation Specifications:Out of specification for impurities.
December 26, 2018DrugsFDA
Pharm D Solutions, LLC recalls Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843
Hazard: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
December 26, 2018DrugsFDA
CBI Laboratories, Inc. recalls Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube, Mfg. Fo
Hazard: Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.