Drug and pharmaceutical recalls
17730 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2017-07-19FDA-DrugOrganic Herbal SupplyClass IRECTALIS Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY --- UPC Code 680474228782
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
- 2017-07-19FDA-DrugOrganic Herbal SupplyClass IXrect Male Enhancement Herbal Dietary Supplement Capsules, 500 mg supplied in 2, 4 and 10 count packages, Distributed by Organic Herbal Supply, Roseville, CA ---- UPC Code 680474015795
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
- 2017-07-19FDA-DrugOrganic Herbal SupplyClass IZRECT Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 852675999451
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
- 2017-07-19FDA-DrugOrganic Herbal SupplyClass ICummor Natural Male Enhancement, Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV --- UPC code #680474229116
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
- 2017-07-19FDA-DrugOrganic Herbal SupplyClass IUPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules, supplied in 2, 4 and 10 count packages, Distributed by AH Distribution, DelRay, Beach, FL ---- UPC Code 680474229260
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
- 2017-07-19FDA-DrugTeva PharmaceuticalsClass IPaliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, NDC: 0591-3693-19
Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.
- 2017-07-19FDA-DrugBristol-myers Squibb CompanyClass IEliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA and Pfizer Inc. New York, NY 10017 USA, NDC 0003-0894-21
Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets only instead of the labeled 5 mg tablets.
- 2017-07-19FDA-DrugAstraZeneca Pharmaceuticals, LPClass IBRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd. for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850; By: AstraZeneca AB, SE-151 85 Sodertalje, Sweden, NDC 0186-0777-08.
Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
- 2017-07-19FDA-DrugBaxter Healthcare CorporationClass II0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distributed in Canada by Baxter Corporation, Toronto, Ontario, Canada, Product Code: 2B1322, NDC 0338-0049-02.
Lack of Assurance of Sterility: Customer complaints for leaking bags.
- 2017-07-19FDA-DrugAdvanced Pharma Inc.Class IIPotassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-922-25
Lack of Assurance of Sterility
- 2017-07-19FDA-DrugAdvanced Pharma Inc.Class IIPotassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-924-25
Lack of Assurance of Sterility
- 2017-07-19FDA-DrugAdvanced Pharma Inc.Class IIPotassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-926-25
Lack of Assurance of Sterility
- 2017-07-19FDA-DrugAdvanced Pharma Inc.Class IIQUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b) 7mL vial (NDC 15082-814-79), c) 10mL vial (NDC 15082-814-61), Repackaged by Advanced Pharm, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404.
Lack of Assurance of Sterility
- 2017-07-12FDA-DrugPhillips Co.Class IIVenomX, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottles, Skin Protectant Phillips Company, Millerton, OK -- NDC 43074-207-01
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
- 2017-07-12FDA-DrugPhillips Co.Class IIStaphWash+Plus+ Skin Protectant, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 43074-101-01
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
- 2017-07-12FDA-DrugPhillips Co.Class IIStingMed Insect bites Skin Protectant. Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 04307-100-11
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
- 2017-07-12FDA-DrugPhillips Co.Class IIDiabecline brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-100-11
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
- 2017-07-12FDA-DrugPhillips Co.Class IITetraStem brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-301-11
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
- 2017-07-12FDA-DrugPhillips Co.Class IITetracycline-ABC Brand Topical ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 4307410201
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
- 2017-07-12FDA-DrugFagron Compounding Services LLC dba Fagron Sterile ServicesClass IISuccinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC 7335968405
Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier
- 2017-07-12FDA-DrugG & W Laboratories, Inc.Class IIIG & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC 0713-0656-31, c) 45 g tube (NDC 0713-0656-37), d) 60 g tube (NDC 0713-0656-60), Rx Only, Manufactured by G & W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080
Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.
- 2017-07-12FDA-DrugGSK Consumer HealthcareClass IIparodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigingivitis Toothpaste, 0.454% (0.15% w/v fluoride ion), 3.4 OZ (96.4 g) tube, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059, NDC 0135-0601-01.
Presence of Foreign Substance: possibility of the presence of metal in the product.
- 2017-07-12FDA-DrugSandoz IncorporatedClass IIIAmitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540
Cross Contamination With Other Product: Imipramine
- 2017-07-12FDA-DrugLantheus MI Radipharmaceuticals Inc.Class IIIFludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lantheus MI Radiopharmaceuticals, Inc., San Juan, PR --- NDC 11994-015-01
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
- 2017-07-12FDA-DrugAlvogen, IncClass IIClindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-464-69
Lack of Assurance of Sterility
- 2017-07-12FDA-DrugAlvogen, IncClass IIClindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-463-69
Lack of Assurance of Sterility
- 2017-07-12FDA-DrugAlvogen, IncClass IIClindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-462-69
Lack of Assurance of Sterility
- 2017-07-12FDA-DrugXttrium Laboratories IncClass IIChlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056, NDC 0116-2001-16
CGMP Deviations
- 2017-07-12FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIMethocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 g container (NDC: 58597-8023-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of quality assurance at the API manufacturer.
- 2017-07-12FDA-DrugPharmedium Services LlcClass IIIBupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-023-09
Labeling: Incorrect or Missing Lot and/or Exp Date
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