September 21, 2022DrugsFDA
Vi-Jon, LLC recalls Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Grape Flavor, 10 FL OZ (296 mL)
Hazard: Microbial contamination of non-sterile products.
September 21, 2022DrugsFDA
Vi-Jon, LLC recalls Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL)
Hazard: Microbial contamination of non-sterile products.
September 21, 2022DrugsFDA
Vi-Jon, LLC recalls Topcare health, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Cherry Flavor, 10 FL OZ (296 mL), D
Hazard: Microbial contamination of non-sterile products.
September 21, 2022DrugsFDA
Vi-Jon, LLC recalls SWAN, Citroma MAGNESIUM CITRATE, Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemony Flavor, 10 FL OZ (296 mL), Dist
Hazard: Microbial contamination of non-sterile products.
September 21, 2022DrugsFDA
Vi-Jon, LLC recalls Rexall, Magnesium Citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Distributed
Hazard: Microbial contamination of non-sterile products.
September 21, 2022DrugsFDA
Vi-Jon, LLC recalls P, magnesium citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Distributed By Pu
Hazard: Microbial contamination of non-sterile products.
September 21, 2022DrugsFDA
Vi-Jon, LLC recalls meijer, magnesium citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Dist. By Mei
Hazard: Microbial contamination of non-sterile products.
September 21, 2022DrugsFDA
Vi-Jon, LLC recalls Kroger, Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), Distributed By The K
Hazard: Microbial contamination of non-sterile products.
September 21, 2022DrugsFDA
Vi-Jon, LLC recalls EQUALINE magnesium citrate saline laxative, oral solution, (1.745 g/fl oz), DYE FREE lemon flavor, 10 FL OZ (296 mL), Di
Hazard: Microbial contamination of non-sterile products.
September 21, 2022DrugsFDA
Vi-Jon, LLC recalls equate Magnesium Citrate, SALINE LAXATIVE, (1.745g/fl oz) 10 FL OZ (296mL), Grape Flavor, Distributed By: Walmart, Inc.
Hazard: Microbial contamination of non-sterile products.
September 21, 2022DrugsFDA
Vi-Jon, LLC recalls CVS Health, Magnesium Citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), a) UPC 0
Hazard: Microbial contamination of non-sterile products.
September 21, 2022DrugsFDA
Edgewell Personal Care Brands, LLC recalls Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.0%, Homosalate 6.0%, Octocrylene 6.0%, pack
Hazard: Chemical contamination: presence of benzene
September 14, 2022DrugsFDA
CIPLA recalls Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cip
Hazard: Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
September 14, 2022DrugsFDA
CIPLA recalls Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton
Hazard: Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
September 14, 2022DrugsFDA
Akorn, Inc. recalls Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL
Hazard: cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
September 14, 2022DrugsFDA
Akorn, Inc. recalls Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045
Hazard: cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60m
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), package
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL in
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Inst
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Ins
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Inst
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Insti
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Institu
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Instit
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Ins
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutiona
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, p
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups pe
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton,
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.