July 31, 2019DrugsFDA
Ascend Laboratories LLC recalls Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx
Hazard: Failed Dissolution Specifications
July 31, 2019DrugsFDA
Baxter Healthcare Corporation recalls 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 6001
Hazard: Lack of Assurance of Sterility: Bags have potential to leak.
July 31, 2019DrugsFDA
Deva Holding AS - Cerkezkoy Subesi recalls Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul
Hazard: CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
July 31, 2019DrugsFDA
Deva Holding AS - Cerkezkoy Subesi recalls Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877-541-14),
Hazard: CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
July 31, 2019DrugsFDA
Deva Holding AS - Cerkezkoy Subesi recalls Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle (NDC 67877-540-14),
Hazard: CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
July 31, 2019DrugsFDA
Deva Holding AS - Cerkezkoy Subesi recalls Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle (NDC 67877-539-14),
Hazard: CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
July 31, 2019DrugsFDA
Deva Holding AS - Cerkezkoy Subesi recalls Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07), b) 14-count bottle (NDC 67877-538-14), R
Hazard: CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
July 31, 2019DrugsFDA
Deva Holding AS - Cerkezkoy Subesi recalls Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14), Rx
Hazard: CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
July 31, 2019DrugsFDA
Pharma-Natural Inc. recalls Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnica), 2.5oz (71 g) roll on bottle, Exclusivel
Hazard: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
July 31, 2019DrugsFDA
Pharma-Natural Inc. recalls NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavo
Hazard: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
July 31, 2019DrugsFDA
Pharma-Natural Inc. recalls SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin), 150 mg) in each 7.5 mL 1 1/2 tsp), GRAPE F
Hazard: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
July 31, 2019DrugsFDA
Pharma-Natural Inc. recalls TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl, 10 mg) in each 5 mL tsp, Grape Flavor, 16
Hazard: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
July 31, 2019DrugsFDA
Pharma-Natural Inc. recalls Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Relieving Topical Analgesic Gel, 4 Oz (113.
Hazard: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
July 31, 2019DrugsFDA
Pharma-Natural Inc. recalls Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz (71 g) roll on bottle, Manufactured & Dist
Hazard: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
July 31, 2019DrugsFDA
Pharma-Natural Inc. recalls Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (113 g) jar, Distributed by Diabetic Supply of
Hazard: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
July 31, 2019DrugsFDA
Pharma-Natural Inc. recalls Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. (56.7 g) jar, Manufactured by: Pamby Distri
Hazard: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
July 31, 2019DrugsFDA
Pharma-Natural Inc. recalls LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.17 Oz (4 g) roll on bottle, Distributed by:
Hazard: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
July 31, 2019DrugsFDA
Pharma-Natural Inc. recalls DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distrib
Hazard: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
July 31, 2019DrugsFDA
Pharma-Natural Inc. recalls GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherr
Hazard: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
July 31, 2019DrugsFDA
Pharma-Natural Inc. recalls ARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manufactured exclusively for: Manufactured excl
Hazard: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
July 31, 2019DrugsFDA
Pharma-Natural Inc. recalls Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with
Hazard: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
July 31, 2019DrugsFDA
Pharma-Natural Inc. recalls ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (73ML) roll on bottle, Manufactured exclusive
Hazard: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
July 31, 2019DrugsFDA
Pharma-Natural Inc. recalls AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufactured exclusively for: Cas, P.O. Box 520248, Mi
Hazard: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
July 31, 2019DrugsFDA
Pharma-Natural Inc. recalls Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pum
Hazard: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
July 31, 2019DrugsFDA
Preferred Pharmaceuticals, Inc recalls Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment, Pkg Size 3 g Tube, Gen
Hazard: CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
July 24, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupi
Hazard: Labeling: Missing label; Product complaints reported missing bottle label.
July 24, 2019DrugsFDA
Fresenius Kabi USA, LLC recalls Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi,
Hazard: Presence of Particulate Matter; glass particulates
July 24, 2019DrugsFDA
Pfizer Inc. recalls Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, I
Hazard: Lack of Assurance of Sterility: Bags have the potential to leak.
July 24, 2019DrugsFDA
Pfizer Inc. recalls Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag, Rx Only, Hospira, In
Hazard: Lack of Assurance of Sterility: Bags have the potential to leak.
July 17, 2019DrugsFDA
First Pharma Associates LLC dba Riverpoint Pharmacy recalls Serum Tears 20% Eye Drops PF Solution, packaged in a) 15 EA, b)15 mL vials, c) 12 EA, Rx only, First Pharma Associates
Hazard: Lack of Assurance of Sterility.