Labeling: Wrong Barcode
Drugs Recalls
Prescription and over-the-counter medications
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.
Amneal Pharmaceuticals of New York
Failed Dissolution Specifications
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01
Regeneron Pharmaceuticals
Lack of Assurance of Sterility: Complaints of syringe breakage
Weiner Boner Honey, 12g packet, 100% Organic Formula.
Pyramids Wholesale
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
FA Online
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5
Aruba Aloe Balm N.V.
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557
Pyramids Wholesale
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13
Second Tokushima Factory, Otsuka Pharmaceutical Co.
Cross Contamination with Other Products
Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455
Pyramids Wholesale
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Samurai-X Honey 6800, UPC 2 56891 27553 3.
Pyramids Wholesale
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13
Second Tokushima Factory, Otsuka Pharmaceutical Co.
Cross Contamination with Other Products
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.
Second Tokushima Factory, Otsuka Pharmaceutical Co.
Cross Contamination with Other Products
ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L
Pyramids Wholesale
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.