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.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIHYDROmorphone HCl Injection in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIEphedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIFentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIFentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIBupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIHYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugAurobindo Pharma Ltd.Class IIIMetformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65862-010-05.
Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
- 2018-02-21FDA-DrugThe Compounding Pharmacy of AmericaClass IHCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of America, 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892
Non-Sterility
- 2018-02-21FDA-DrugAMERICAN HEALTH PACKAGINGClass IIAripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
- 2018-02-21FDA-DrugTeva Pharmaceuticals USAClass IIIFluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56
Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
- 2018-02-21FDA-DrugPharMEDium Services, LLCClass II100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
- 2018-02-21FDA-DrugPharMEDium Services, LLCClass II0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
- 2018-02-21FDA-DrugPharMEDium Services, LLCClass II15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
- 2018-02-21FDA-DrugWebrx dba RxPalace.comClass IIIBonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spray bottles, Manufactured by WebRx Pharmacy Palace, Sarasota, FL 34232; NDC 70582-999-74
CGMP Deviations: not manufactured according to current good manufacturing practices.
- 2018-02-21FDA-DrugSun Pharmaceutical Industries, Inc.Class IIIAzelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutical Ind. Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol - 389 350, Gujarat, India --- NDC 47335-779-91
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
- 2018-02-21FDA-DrugGenentech, Inc.Class IIIKlonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Member of the Roach Group, 1 DNA Way South San Francisco, CA 94080-4990. NDC 0004-0068-01
Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
- 2018-02-21FDA-DrugHetero Labs Limited Unit VClass IIFamciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30
Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
- 2018-02-21FDA-DrugBYL Solutions Inc.Class IIIBull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Technology CO., LTD, BYL Solutions, Inc. dba Nutra Labs, Inc., Palmetto, FL
Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil
- 2018-02-21FDA-DrugALLERGANClass IIINORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01.
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
- 2018-02-21FDA-DrugSage Products IncClass IINose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System. Contains: Three 2-packs of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation and One 7ml Burst Pouch of Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, I Ultra-Soft Toothbrush, 1 Applicator Swab treated with Sodium Bicarbonate. 1 Bottle of 3M Skin and Nasal Antiseptic (Povidone-Iodine Solution 5%w/w (0.5%available iodine) USP) Patient Preoperative Skin Preparation 0.14 fl oz (4ml), 4 sterile s
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- 2018-02-21FDA-DrugSage Products IncClass IISkin antisepsis and oral cleansing. Contains Three 2-packs of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation and One 7ml Burst Pouch of Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, I Ultra-Soft Toothbrush, 1 Applicator Swab treated with Sodium Bicarbonate. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9009 UPC 6 18029 79140 5
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- 2018-02-21FDA-DrugSage Products IncClass IIQ Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 1 Untreated Suction Toothbrush packages, 1 Single dose bottle of 0.12% CHG Oral Rinse, 2 Suction Oral Swab packages with Perox-A-Mint, 1 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9002 UPC 6 18029 83025 8
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- 2018-02-21FDA-DrugSage Products IncClass IIQ Care Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6994 UPC 6 18029 83094 4
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- 2018-02-21FDA-DrugSage Products IncClass IIQ Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Petite Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Petite Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6974-S UPC 6 18029 83097 5
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- 2018-02-21FDA-DrugSage Products IncClass IIQ Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Petite Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Petite Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6974 UPC 6 18029 83097 5
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- 2018-02-21FDA-DrugSage Products IncClass IIQ.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 1 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6964 UPC 6 18029 83075 3
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- 2018-02-21FDA-DrugSage Products IncClass IIQ.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6924 UPC 6 18029 83033 3
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- 2018-02-21FDA-DrugSage Products IncClass IIQ.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated, CHG Compatible Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6922-B UPC 6 18029 83032 6
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- 2018-02-21FDA-DrugSage Products IncClass IIQ.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated, CHG Compatible Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6922 UPC 6 18029 83032 6
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- 2018-02-21FDA-DrugSage Products IncClass IIQ.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6914-S UPC 6 18029 83017 3
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
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