Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Drugs Recalls
Prescription and over-the-counter medications
Failed Dissolution Specifications
Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per mL), Rx only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478
Pharmedium Services
cGMP deviations
Estradiol 12.5 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
TM (ALP 50/PAPAV 30/PHENT1.5 mg), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Testosterone/Finasteride 80 mg/8 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Estradiol 35 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Testosterone 55 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Estradiol 15 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Testosterone 37.5 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Methionine15mg/Inositol 50mg/Choline 100mg, packaged in a) 5mL and b) 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Estradiol 20 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
B-complex (B1-200mg, B2-4mg, B3-200mg,B5-4mg,B6-4mg) /mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
CoEnzymeQ10 25mg/mL, 5mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Estradiol 40 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Microbial Contamination of Non-Sterile Products
Ascorbic Acid (Tapioca) 500 mg/mL, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Testosterone 100 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
MVI-7 (B1-100mg/B3-100mg, B5-252 mg, B6-102mg, Vit C-2500 mg, B12-10mg, Mag-1000 mg)/ vial liquid injectable, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30-count pouch, Distributed by Better Planet Brands, Fort Lauderdale, FL 33316, UPC 8 54049 00358 0.
Diamond Wipes International
CGMP Deviations: finished products were manufactured with poor quality water.