Drug and pharmaceutical recalls
17625 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2017-07-12FDA-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
- 2017-07-12FDA-DrugPharmedium Services LlcClass IIIBupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 270 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-044-57
Labeling: Incorrect or Missing Lot and/or Exp Date
- 2017-07-12FDA-DrugPharmedium Services LlcClass IIIRopivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium Chloride Injection, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-100-13
Labeling: Incorrect or Missing Lot and/or Exp Date
- 2017-07-12FDA-DrugPharmedium Services LlcClass IIIRopivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 600 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-279-33
Labeling: Incorrect or Missing Lot and/or Exp Date
- 2017-07-12FDA-DrugPharmedium Services LlcClass IIIRopivacaine HCl 0.2% 500 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: 61553-258-25
Labeling: Incorrect or Missing Lot and/or Exp Date
- 2017-07-12FDA-DrugPharmedium Services LlcClass IIIRopivacaine HCl 0.2% 500 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: 61553-258-03
Labeling: Incorrect or Missing Lot and/or Exp Date
- 2017-07-12FDA-DrugPharmedium Services LlcClass IIIRopivacaine HCl 0.2% 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: 61553-256-09
Labeling: Incorrect or Missing Lot and/or Exp Date
- 2017-07-05FDA-DrugAllergan Sales, LLCClass IIBlephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured by Allergan, Irvine, California, 92612, U.S.A., NDC: 0023-0313-04.
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
- 2017-07-05FDA-DrugMckesson Packaging ServicesClass IIIBuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center, Suite 400, Princeton, NJ 08805, NDC: 63739-706-10
Failed Moisture Limits: Product tested out-of-specification for moisture content.
- 2017-07-05FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIDoxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4), b) 100 g packaged in 16 oz container (NDC: 58597-8082-6), c) 500 g packaged in a 2500 cc container (NDC: 58597-8082-7) and a 1,000 g packaged in 1 gallon container (NDC: 58597-8082-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
- 2017-07-05FDA-DrugSanofi-Aventis U.S. LLCClass IIIGaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count bottles, Distributed by: GlaxoSmithKline Consumer Healthcare, L.P., Moon Twp, PA 15108, UPC 3 0088-1175-47 8.
Superpotent Drug: high out-of-specification result for magnesium.
- 2017-07-05FDA-DrugL. Perrigo CompanyClass IIIWalgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two plastic 12FL OZ (355 mL) bottles connected by one paper sleeve, TOTAL 24 FL OZ (1.5 pt)(710 mL), OTC, Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015
Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the product twin pack. The incorrect product sleeve is for Day-Night Cold and Flu whereas the batch contains Day-Night Cough Liquid.
- 2017-07-05FDA-DrugApothecary By DesignClass IIProgesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Street, Portland, ME.
Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.
- 2017-07-05FDA-DrugNoven Pharmaceuticals, Inc.Class IIIMinivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
- 2017-06-28FDA-DrugVi-Jon, Inc.Class IIMagnesium Citrate Saline Laxative Cherry Flavored, packaged in a) 10 fl. oz. (296 mL) bottle UPC: 072785104556 (Rexall's label), b) 10 fl. oz. (296 mL) bottle UPC: 041163254138 (Equaline's label), OTC, Distributed by a) Dolgencorp, LL, Goodlettsville, TN 37072 b)Supervalu, Inc. Eden Prairie, MN 55344
Presence of foreign substance: glass particle
- 2017-06-28FDA-DrugLucid Pharma LLCClass IIVenlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg, packaged in a) 30-count bottles (NDC 52343-132-30) and b) 90-count bottles (NDC 52343-132-90), Rx only, Distributed by: Lucid Pharma LLC, 2 Tower Center Blvd, Suite-1101-B, East Brunswick, NJ 08816 USA.
Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules.
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