June 19, 2019DrugsFDA
Pharm D Solutions, LLC recalls Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Hazard: Lack of Sterility Assurance.
June 19, 2019DrugsFDA
Pharm D Solutions, LLC recalls Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Hazard: Lack of Sterility Assurance.
June 19, 2019DrugsFDA
Pharm D Solutions, LLC recalls Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Hazard: Lack of Sterility Assurance.
June 19, 2019DrugsFDA
Pharm D Solutions, LLC recalls Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Hazard: Lack of Sterility Assurance.
June 19, 2019DrugsFDA
Pharm D Solutions, LLC recalls Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Hazard: Lack of Sterility Assurance.
June 19, 2019DrugsFDA
Pharm D Solutions, LLC recalls Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-84
Hazard: Lack of Sterility Assurance.
June 19, 2019DrugsFDA
Pharm D Solutions, LLC recalls Nandrolone Decanoate 200 mg/mL Injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77
Hazard: Lack of Sterility Assurance.
June 19, 2019DrugsFDA
Pharm D Solutions, LLC recalls Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50mg, Choline Chloride, FCC 100 mg) 10 mL Inje
Hazard: Lack of Sterility Assurance.
June 19, 2019DrugsFDA
Pharm D Solutions, LLC recalls Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844
Hazard: Lack of Sterility Assurance.
June 19, 2019DrugsFDA
Pharm D Solutions, LLC recalls Human Chorionic Gonadotropin 12,000 IU vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Hazard: Lack of Sterility Assurance.
June 19, 2019DrugsFDA
Pharm D Solutions, LLC recalls Human Chorionic Gonadotropin 5,000 IU vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-
Hazard: Lack of Sterility Assurance.
June 19, 2019DrugsFDA
Pharm D Solutions, LLC recalls Human Chorionic Gonadotropin 10,000 IU vials, Rx only Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844
Hazard: Lack of Sterility Assurance.
June 19, 2019DrugsFDA
Pharm D Solutions, LLC recalls B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg, Depanthenol 5mg) injectable, 10 mL vials,
Hazard: Lack of Sterility Assurance.
June 19, 2019DrugsFDA
Pharm D Solutions, LLC recalls Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6
Hazard: Lack of Sterility Assurance.
June 5, 2019DrugsFDA
Stiff Boy LLC recalls The Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4 Capsules per
Hazard: Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.
June 5, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin
Hazard: Complaint received of metal piece identified in the product bottle prior to the reconstitution.
June 5, 2019DrugsFDA
Inopak Ltd recalls Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with exclusive Bajan fragr
Hazard: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
June 5, 2019DrugsFDA
Inopak Ltd recalls Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers, a) 1000 ml pouches, 10
Hazard: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
June 5, 2019DrugsFDA
Inopak Ltd recalls Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000,
Hazard: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
June 5, 2019DrugsFDA
Inopak Ltd recalls Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 x 1000 ml Disc Pump
Hazard: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
June 5, 2019DrugsFDA
Inopak Ltd recalls Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhe
Hazard: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
June 5, 2019DrugsFDA
Inopak Ltd recalls INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC
Hazard: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
June 5, 2019DrugsFDA
Inopak Ltd recalls INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX, 800ml/27fl.oz.pouches (NDC 058575-110
Hazard: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
June 5, 2019DrugsFDA
Inopak Ltd recalls Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless Hand Sanitizing Gel with
Hazard: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
June 5, 2019DrugsFDA
Inopak Ltd recalls AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ
Hazard: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
June 5, 2019DrugsFDA
Inopak Ltd recalls ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a)
Hazard: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
June 5, 2019DrugsFDA
Avella of Deer Valley, Inc. Store 38 recalls Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA SPECIALTY PHARMACY 24416 N. 19TH AVENUE PHOE
Hazard: Lack of assurance of sterility
May 29, 2019DrugsFDA
Novartis Pharmaceuticals Corp. recalls Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New J
Hazard: Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
May 29, 2019DrugsFDA
Septodont Inc. recalls Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7 mL each, Rx only, Manufactur
Hazard: Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL.
May 29, 2019DrugsFDA
MALLINCKRODT PHARMACEUTICALS recalls Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64
Hazard: Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.