February 1, 2023DrugsFDA
Pharmacy Innovations recalls Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, Rx Only, Pharmacy Innovations, 2936 W 17th St.,
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls Cholecalciferol (Vitamin D3) 100,000U/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls Ceftazidime Intravitreal (1ML vial) 22.5 MG/ML(2.25MG/0.1ML) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St.,
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls Buprenorphine HCL 0.9 MG/ML (25ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls BSS Plus/Lidocaine Opth 1% (1ML syringe) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls Atropine sulfate 0.05%, 1ML dropper, and Atropine sulfate 0.01%, 1 ML dropper, Rx Only, Pharmacy Innovations, 2936 W 17t
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls Apomorphine HCL 2MG/ML (10ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only, Pharmacy Innovations, 2936 W 17t
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls Acetylcysteine 10% Ophthalmic Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls 5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls Minoxidil 0.75% (1.5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls Methylcobalamin 1MG/ML (1ML vial); Methylcobalamin 3MG/ML (1ML vial); Methylcobalamin 5MG/ML (1ML vial) INJECTABLE, Rx O
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls Hydroxocobalamin 25MG/ML (2ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls Chlorpheniramine/Hyoscyamine (1ML) 10MG/0.25MG/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls Dutasteride 0.1% (1.5ML VIAL) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pfizer Inc. recalls Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton,
Hazard: Presence of Particulate Matter: Glass particulate matter detected in injectable.
February 1, 2023DrugsFDA
Glaxosmithkline Consumer Healthcare Holdings DBA Haleon recalls Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled
Hazard: Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
February 1, 2023DrugsFDA
Glaxosmithkline Consumer Healthcare Holdings DBA Haleon recalls Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules
Hazard: Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
February 1, 2023DrugsFDA
Glaxosmithkline Consumer Healthcare Holdings DBA Haleon recalls Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 0573 0154 60 4), and b) 200-count bottles (UP
Hazard: Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
February 1, 2023DrugsFDA
Spectrum Laboratory Products, Inc. recalls Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)1
Hazard: Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
February 1, 2023DrugsFDA
Spectrum Laboratory Products, Inc. recalls Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged by S
Hazard: Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
February 1, 2023DrugsFDA
Nephron Sc Inc recalls Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vi
Hazard: CGMP Deviations: potential for trace amounts of product carryover.
February 1, 2023DrugsFDA
Nephron Sc Inc recalls 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 450
Hazard: CGMP Deviations: potential for trace amounts of product carryover.
February 1, 2023DrugsFDA
Nephron Sc Inc recalls S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch
Hazard: Short Fill
February 1, 2023DrugsFDA
Nephron Sc Inc recalls Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each i
Hazard: Short Fill
February 1, 2023DrugsFDA
Lupin Pharmaceuticals Inc. recalls Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Mar
Hazard: Subpotent Drug: Low assay result observed during long-term stability testing.
February 1, 2023DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare, Inc; Durham, NC, PREFERRED Pharma
Hazard: Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.
February 1, 2023DrugsFDA
OurPharma LLC recalls FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPha
Hazard: Short Fill: Underfilled units.
February 1, 2023DrugsFDA
Ascend Laboratories, LLC recalls Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Labor
Hazard: Failed Dissolution Specification
February 1, 2023DrugsFDA
Ascend Laboratories, LLC recalls Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Labora
Hazard: Failed Dissolution Specification