April 25, 2018DrugsFDA
Partell Specialty Pharmacy recalls Naltrexone 200 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 8911
Hazard: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
April 25, 2018DrugsFDA
Partell Specialty Pharmacy recalls Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. East
Hazard: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
April 25, 2018DrugsFDA
Partell Specialty Pharmacy recalls Vitamin D 50,000 unit/ml, 5 mL amber vial, Injectable Liquid, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave.
Hazard: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
April 25, 2018DrugsFDA
Partell Specialty Pharmacy recalls TM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable solution, packaged in 3 mL amber vial, Rx only, Partell Specialty Pharm
Hazard: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
April 25, 2018DrugsFDA
Partell Specialty Pharmacy recalls Testosterone Cypionate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Ve
Hazard: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
April 25, 2018DrugsFDA
Partell Specialty Pharmacy recalls Nandrolone decanoate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vega
Hazard: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
April 25, 2018DrugsFDA
Partell Specialty Pharmacy recalls Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, packaged in a) 5 mL amber vial and b) 50mL amber vial, Rx only, Par
Hazard: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
April 25, 2018DrugsFDA
Partell Specialty Pharmacy recalls Methionine15mg/Inositol 50mg/Choline 100mg, packaged in a) 5mL and b) 50 mL amber vial, Rx only, Partell Specialty Pharm
Hazard: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
April 25, 2018DrugsFDA
Partell Specialty Pharmacy recalls Lipoic Acid 25mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 8911
Hazard: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
April 25, 2018DrugsFDA
Partell Specialty Pharmacy recalls HCG 1000 units/mL, packaged in a) 2 mL and b) 6 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave.
Hazard: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
April 25, 2018DrugsFDA
Partell Specialty Pharmacy recalls Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 891
Hazard: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
April 25, 2018DrugsFDA
Partell Specialty Pharmacy recalls CoEnzymeQ10 25mg/mL, 5mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119
Hazard: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
April 25, 2018DrugsFDA
Partell Specialty Pharmacy recalls Biotin Suspension 10mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, N
Hazard: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
April 25, 2018DrugsFDA
Partell Specialty Pharmacy recalls B-complex (B1-200mg, B2-4mg, B3-200mg,B5-4mg,B6-4mg) /mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S.
Hazard: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
April 25, 2018DrugsFDA
Partell Specialty Pharmacy recalls Ascorbic Acid (Tapioca) 500 mg/mL, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, L
Hazard: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
April 25, 2018DrugsFDA
AVKARE Inc. recalls Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN
Hazard: Failed Dissolution Specifications
April 25, 2018DrugsFDA
Pharmedium Services, LLC recalls Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per mL), Rx only, PharMEDium Services
Hazard: cGMP deviations
April 25, 2018DrugsFDA
Sandoz Incorporated recalls Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc.,
Hazard: Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
April 25, 2018DrugsFDA
Diamond Wipes International, Inc. recalls WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dist. by Diamond Wipes Int'l, Inc., Chino, CA
Hazard: CGMP Deviations: finished products were manufactured with poor quality water.
April 25, 2018DrugsFDA
Diamond Wipes International, Inc. recalls ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30-count pouch, Distributed by Better Planet
Hazard: CGMP Deviations: finished products were manufactured with poor quality water.
April 25, 2018DrugsFDA
Marcas Usa Llc recalls PASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 gram tube, UPC #851357003004, NDC #75940-111
Hazard: Microbial Contamination of Non-Sterile Products
April 25, 2018DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 6
Hazard: Defective Delivery System: Out of specification for adhesive transfer.
April 18, 2018DrugsFDA
InvaGen Pharmaceuticals, Inc. recalls Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla
Hazard: Failed impurities/degradation specifications: Failure to water content and impurity
April 18, 2018DrugsFDA
Lake Erie Medical & Surgical Supply Inc recalls Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Quality Care Products, Temperance, MI 48182 Mfr
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date
April 18, 2018DrugsFDA
United Pacific Co Ltd recalls Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02
Hazard: CGMP Deviations: the product was produced with substandard GMP manufacturing processes.
April 18, 2018DrugsFDA
Elroselabs Inc. recalls Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC, Manufactured for Elrose Labs, Inc., Sanford,
Hazard: cGMP Deviations
April 18, 2018DrugsFDA
Elroselabs Inc. recalls Molleave, 2 oz bottle, OTC, Manufactured for Elrose Labs, Inc.
Hazard: cGMP Deviations
April 18, 2018DrugsFDA
Elroselabs Inc. recalls Conzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 (22g), Elrose Labs, Sanford Fl 32771 USA --- NDC 702
Hazard: cGMP Deviations
April 11, 2018DrugsFDA
InvaGen Pharmaceuticals, Inc. recalls buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-
Hazard: Failed Dissolution Specifications; during stability testing
April 11, 2018DrugsFDA
InvaGen Pharmaceuticals, Inc. recalls buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc.
Hazard: Failed Dissolution Specifications; during stability testing