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.
- 2017-02-08FDA-DrugEcolab, Inc.Class IIIEndure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in plastic (HDPE) bottles, Over-the-counter, Model Number: 61430436 (800 mL, 12 bottles/case) - United States; Model Number: 6000179 (800 mL, 12 bottles/case) - Canada, Ecolab, St. Paul, MN 55102, NDC 47593-265-36
Subpotent Drug
- 2017-02-08FDA-DrugHetero Drugs Ltd. - Unit 1Class IIIFinasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
- 2017-02-08FDA-DrugDr. Reddy's Laboratories, Inc.Class IIFlucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Failed Dissolution Specifications; 18 month stability time point
- 2017-02-08FDA-DrugDr. Reddy's Laboratories, Inc.Class IIFlucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12
Failed Dissolution Specifications; 18 month stability time point
- 2017-02-08FDA-DrugDr. Reddy's Laboratories, Inc.Class IIFlucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Failed Dissolution Specifications; 18 month stability time point
- 2017-02-08FDA-DrugDr. Reddy's Laboratories, Inc.Class IIFlucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Failed Dissolution Specifications; 18 month stability time point
- 2017-02-01FDA-DrugRoxane Laboratories, Inc.Class IIIAzelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
- 2017-02-01FDA-DrugCambrex Charles City IncClass IIMesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside Poly-lined cardboard drums. Net weight 40 kg
Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
- 2017-02-01FDA-DrugSun Pharmaceutical Industries, Inc.Class IIIbuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86
Failed Dissolution Specifications; 18 month stability time point
- 2017-02-01FDA-DrugSun Pharmaceutical Industries, Inc.Class IIIbuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India
Failed Dissolution Specifications; 18 month stability time point
- 2017-02-01FDA-DrugMylan LLC.Class IITemozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
- 2017-02-01FDA-DrugMylan LLC.Class IITemozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
- 2017-02-01FDA-DrugMylan LLC.Class IITemozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
- 2017-02-01FDA-DrugMylan LLC.Class IITemozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
- 2017-02-01FDA-DrugTeva Pharmaceuticals USAClass IIAmoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73
Subpotency: due to a low, out of specification test result for assay during stability testing.
- 2017-02-01FDA-DrugActavis IncClass IIIAlbuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
- 2017-02-01FDA-DrugVintage Pharmaceuticals LLC dba Qualitest PharmaceuticalsClass IIIDEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
Failed Impurities/ Degradation Specifications
- 2017-02-01FDA-DrugRoxane Laboratories, Inc.Class IIFurosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
- 2017-01-25FDA-DrugTown and Country Compounding and Consultation Services, LLCClass IIIHCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459
Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).
- 2017-01-25FDA-DrugSandoz IncClass IIIDonepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz Inc., Princeton, NJ 08540.
Subpotent Drug: out of specification results for assay test.
- 2017-01-25FDA-DrugL. Perrigo CompanyClass IIClindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel, Distributed by Perrigo, Allegan, MI --- NDC 45802-736-84, UPC 345802736840
Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
- 2017-01-25FDA-DrugNovum Pharma, LLCClass IIINovacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0 g sample packets), NDC 69646-704-38 (10 ct. Carton of 1gm samples) / NDC 69646-704-01 (Individual 1gm Samples within Carton), Rx Only, Novum Pharma LLC, Chicago, IL 60654
Subpotent Drug: Out of specification result for pramoxine hydrochloride
- 2017-01-25FDA-DrugShire PLCClass IIIPentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
- 2017-01-25FDA-DrugTeva Pharmaceuticals USAClass IIIRisedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
Failed Dissolution Specifications
- 2017-01-18FDA-DrugNoven Pharmaceuticals, Inc.Class IIDaytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5555-3.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
- 2017-01-18FDA-DrugNoven Pharmaceuticals, Inc.Class IIDaytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
- 2017-01-18FDA-DrugNoven Pharmaceuticals, Inc.Class IIDaytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 30 count per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc, Miami, FL 33186, NDC 68968-5552-3
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
- 2017-01-18FDA-DrugPharm D Solutions, LLCClass IIIHCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1723-20
Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct
- 2017-01-18FDA-DrugPharm D Solutions, LLCClass IIITestosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1709-04
Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct
- 2017-01-18FDA-DrugBaxter Healthcare CorporationClass II10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, NDC 0338-1130-06
Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.
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