Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2019-07-31FDA-DrugPharma-Natural Inc.Class IIARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manufactured exclusively for: Manufactured exclusively for: Crossover Telecom, LLC., P.O. Box 520248, Miami, FL 33122, UPC 8 50993 00461 1.
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
- 2019-07-31FDA-DrugPharma-Natural Inc.Class IIOliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63766-119-04.
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
- 2019-07-31FDA-DrugPharma-Natural Inc.Class IIARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (73ML) roll on bottle, Manufactured exclusively for: Crossover Telecom, LLC., P.O. Box 520248, Miami, FL 33122, UPC 8 50993 00408 6.
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
- 2019-07-31FDA-DrugPharma-Natural Inc.Class IIAbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufactured exclusively for: Cas, P.O. Box 520248, Miami, FL 33152, UPC 8 50993 00402 4.
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
- 2019-07-31FDA-DrugPharma-Natural Inc.Class IIOliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63788-120-04.
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
- 2019-07-31FDA-DrugPreferred Pharmaceuticals, IncClass IINeomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment, Pkg Size 3 g Tube, Generic for: Maxitrol, For External Use Only, Rx only, Mfg: Paddock Laboratories, LLC, Preferred Pharmaceuticals, Inc., The Physicians Solutions, Anaheim, CA, NDC 68788-9373-03.
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
- 2019-07-24FDA-DrugLupin Pharmaceuticals Inc.Class IIIGatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01.
Labeling: Missing label; Product complaints reported missing bottle label.
- 2019-07-24FDA-DrugFresenius Kabi USA, LLCClass IFluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand]
Presence of Particulate Matter; glass particulates
- 2019-07-24FDA-DrugPfizer Inc.Class IIMilrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-23, Barcode (01)00304092776233.
Lack of Assurance of Sterility: Bags have the potential to leak.
- 2019-07-24FDA-DrugPfizer Inc.Class IIMilrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-02, Barcode (01)00304092776028.
Lack of Assurance of Sterility: Bags have the potential to leak.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IISerum Tears 20% Eye Drops PF Solution, packaged in a) 15 EA, b)15 mL vials, c) 12 EA, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343- 6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IIGlutathione 100 mg/mL Inhalation Solution (PF), 45 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IIChorionic Gonadotropin 2,000U/mL PF Injection, 8 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IIPAP/PHEN/PGE1 18 mg/0.6mg/5.88mcg/mL Injection, 5 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IIPAP/PHEN/PGE1 30 mg/0.83mg/10mcg/mL Injection, 5 mL, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IIPAP/PHEN/PGE1 30 mg/2mg/20mcg/mL Injection, 10mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IIPAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection, 5mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IIMethylcobalamin 10 mg/mL Injection, 5.4 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IIMethylcobalamin 1 mg/mL Injection, 8 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IIHydroxocobalamin 10 mg/mL Injection (ALT) Solution, 30 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IIProstaglandin 20 mcg/mL/Procaine 0.1% Injection, packaged in a) 2.5mL and b)10 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205 (509) 343-6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IIHydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection, 5 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IITestosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/mL Injection, 3mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IITestosterone Cypionate 100 mg/mLOil Injection Injection, 12 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IITestosterone Cypionate 200 mg/mL Ethyl Oleate Injection, packaged in a) 7.2 mL. b) 9.6 mL, c) 10.8mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IITestosterone Cypionate 200 mg/mL Sesame Oil Injection, packaged in a) 9 mL, b) 12 mL vials, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343- 6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IITestosterone Cypionate 150 mg/mL Sesame Oil Injection, 12 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343- 6252.
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IITestosterone Cypionate 100 mg/mL Sesame Oil Injection, 12mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugAmerican Health PackagingClass IIAnastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
- 2019-07-17FDA-DrugMAJOR PHARMACEUTICALSClass IILosartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Get notified about new drug recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief