May 1, 2024DrugsFDA
Nomax Inc recalls GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-0
Hazard: 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.
May 1, 2024DrugsFDA
HONEYWELL INC recalls Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face
Hazard: CGMP Deviations
May 1, 2024DrugsFDA
Aruba Aloe Balm N.V. recalls Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm I
Hazard: Chemical Contamination: Product manufactured with ethanol API that contains methanol
May 1, 2024DrugsFDA
Aruba Aloe Balm N.V. recalls Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC
Hazard: Chemical Contamination: Product manufactured with ethanol API that contains methanol
May 1, 2024DrugsFDA
Pyramids Wholesale Inc. recalls HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A
Hazard: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
May 1, 2024DrugsFDA
Pyramids Wholesale Inc. recalls ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L
Hazard: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
May 1, 2024DrugsFDA
Pyramids Wholesale Inc. recalls The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130 Maccormick Ave, Suite 105, Costa Me
Hazard: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
May 1, 2024DrugsFDA
Pyramids Wholesale Inc. recalls SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762
Hazard: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
May 1, 2024DrugsFDA
Pyramids Wholesale Inc. recalls libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.
Hazard: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
May 1, 2024DrugsFDA
Pyramids Wholesale Inc. recalls GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.
Hazard: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
May 1, 2024DrugsFDA
Pyramids Wholesale Inc. recalls Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557
Hazard: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
May 1, 2024DrugsFDA
Pyramids Wholesale Inc. recalls Samurai-X Honey 6800, UPC 2 56891 27553 3.
Hazard: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
May 1, 2024DrugsFDA
Pyramids Wholesale Inc. recalls Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646.
Hazard: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
May 1, 2024DrugsFDA
Pyramids Wholesale Inc. recalls Weiner Boner Honey, 12g packet, 100% Organic Formula.
Hazard: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
May 1, 2024DrugsFDA
Pyramids Wholesale Inc. recalls Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455
Hazard: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
April 24, 2024DrugsFDA
Specialty Process Labs LLC recalls S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix,
Hazard: Failed Stability Specifications
April 24, 2024DrugsFDA
Specialty Process Labs LLC recalls S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs
Hazard: Failed Stability Specifications
April 24, 2024DrugsFDA
Eli Lilly & Company recalls Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Li
Hazard: CGMP Deviations
April 24, 2024DrugsFDA
AvKARE recalls Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pul
Hazard: Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
April 24, 2024DrugsFDA
Novitium Pharma LLC recalls Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Dri
Hazard: Failed Impurities/Degradation Specifications
April 24, 2024DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 15
Hazard: Superpotent Drug: Due to overfilling of drug powder
April 24, 2024DrugsFDA
Esperion recalls NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Ther
Hazard: Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
April 17, 2024DrugsFDA
Eugia US LLC recalls Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. i
Hazard: Presence of Particulate Matter
April 17, 2024DrugsFDA
Teva Pharmaceuticals USA, Inc recalls Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceutical
Hazard: Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
April 17, 2024DrugsFDA
NATCO Pharma Limited recalls Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottl
Hazard: CGMP Deviations
April 17, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryla
Hazard: Subpotent Drug
April 10, 2024DrugsFDA
SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx On
Hazard: Lack of Assurance of Sterility: Firm did not perform process validation.
April 10, 2024DrugsFDA
SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This
Hazard: Lack of Assurance of Sterility: Firm did not perform process validation.
April 10, 2024DrugsFDA
X-Gen Pharmaceuticals Inc. recalls Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, A
Hazard: Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
April 10, 2024DrugsFDA
X-Gen Pharmaceuticals Inc. recalls Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx
Hazard: Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.