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.
- 2017-11-01FDA-DrugBecton Dickinson & CompanyClass IIChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11
Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IINorepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025014801
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIVANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025007001
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIVANCOmycin 1.5 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025002501
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IISuccinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025088801
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIRopivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226 NDC 7025006301
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIOXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025000101
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IINorepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011501
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIMidazolam HCL 100 mg (1mg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025016201
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIMagnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025003201
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIHydromorphone HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025001001.
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIfentanyl citrate (PF) 1100 mcg (20 mcg/mL) 55 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011001
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIfentaNYL citrate 1000 mcg (10 mcg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025011001
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025024801
Lack of Assurance of Sterility.
- 2017-11-01FDA-DrugBanner Pharmacy Services, LLCClass IIDiltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025018601
Lack of Assurance of Sterility.
- 2017-10-25FDA-DrugThe Harvard Drug GroupClass IIAlprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-5858-61.
Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
- 2017-10-25FDA-DrugRXQ Compounding LLCClass IImethylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10
Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
- 2017-10-25FDA-DrugDeserving Health International CorpClass IISymbio Muc Eye, 0.17 fl.oz. 5mL bottles, Manufactured for and distributed in the US b: Biological Health Group Corp. Bremerton, WA 98337. NDC 69711-125-61
Lack of Assurance of Sterility
- 2017-10-25FDA-DrugUnichem Pharmaceuticals Usa IncClass IIBisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa, 403 511, India, Marketed by: UNICHEM PHARMACEUTICALS, (USA), INC. Hasbrouck Heights, NJ 07604, NDC 29300-126-13.
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
- 2017-10-18FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIFamotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, b) Equate Famotidine, NDC 49035-118-30, Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, Made in India
Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.
- 2017-10-18FDA-DrugUnited PharmacyClass IIGlutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd Ste. 120-121 West Palm Beach, FL 33417
CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
- 2017-10-18FDA-DrugBoehringer Ingelheim Pharmaceuticals, Inc.Class IIIMobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Lic. from: BI Int'l GmbH, Made in Italy, NDC 0597-0030-01
Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
- 2017-10-11FDA-DrugVi-Jon, Inc.Class IIIMagnesium Citrate Oral Solution Cherry Flavor, 1.745 g per fl oz, packaged in 10 fl. oz ( 296 mL) bottles, Labeled as a) CVS Health, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; NDC 6984238038, UPC 050428418321, b) Meijer, Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544, NDC 4125038038, UPC 708820824294, c) Life Brand, Manufactured for: Shoppers Drug Mark/Pharmaprix Toronto, UPC 057800856405
Failed Impurities/Degradation Specifications.
- 2017-10-11FDA-DrugVi-Jon, Inc.Class IIIMagnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in 10 fl. oz. (296 mL) bottles, Labeled as a) CVS Health, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; NDC 59779-667-38, UPC 05042842790; b) Swan Citroma, Distributed by: Vi-Jon One Swan Drive Smyrna, TN 37167, NDC 0869066738, UPC 308690667382; c) GoodSense, Distributed By: Geiss, Destin & Dunn, Inc. Peachtree City, GA 30269, NDC 50804-667-38, UPC 846036007374; d) Leader, Distributed By: Card
Failed Impurities/Degradation Specifications.
- 2017-10-11FDA-DrugInopak LtdClass IIChoice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD, Ringwood, NJ
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
- 2017-10-11FDA-DrugInopak LtdClass IIMild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Disc Pump, 800 mL Universal Valve, and 1 gallon bottles, Inopak. Ltd, Ringwood, NJ 07456
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
- 2017-10-11FDA-DrugInopak LtdClass IIOption Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood, NJ --- NDC 5031-431-02
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
- 2017-10-11FDA-DrugPfizer Inc.Class IIICheck Pfizer Deferoxamine Mesylate lot 51275DD
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
- 2017-10-04FDA-DrugSandoz IncClass IIIAmpicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), Rx only, Manufactured in Austria by Sandoz GmbH or Sandoz Inc., Princeton, NJ 08540.
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
- 2017-10-04FDA-DrugTeva Pharmaceuticals USAClass IIAcarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 16252-523-01.
Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.
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