Drug and pharmaceutical recalls
17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2017-02-01FDA-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.
- 2017-01-18FDA-DrugPfizer Inc.Class IIICytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
- 2017-01-11FDA-DrugWells Pharmacy Network LLCClass IITestosterone Cypionate in Sesame Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugWells Pharmacy Network LLCClass IITestosterone Cypionate in Grapeseed Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugWells Pharmacy Network LLCClass IIVitamin D3 in Sesame Oil Injectable 50,000 IU/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugWells Pharmacy Network LLCClass IIVitamin D3 in Sesame Oil Injectable 100,000 IU/mL, 5 mL, vial, Compounded by Wells Pharmacy, Ocala, FL
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugWells Pharmacy Network LLCClass IITri-Test 200 (CEP 100-75-25) Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugWells Pharmacy Network LLCClass IITrimix Injectable 30 mg/3 mg/60 mcg/mL, a) 2 mL, b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugWells Pharmacy Network LLCClass IITrimix Injectable 30 mg/3 mg/100 mcg/mL, a) 5 mL and 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugWells Pharmacy Network LLCClass IITrimix Injectable 30 mg/1 mg/25 mcg/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugWells Pharmacy Network LLCClass IITrimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugWells Pharmacy Network LLCClass IITrimix Injectable 17.65 mg/0.59 mg/5.9 mcg/mL a) 2 mL, b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugWells Pharmacy Network LLCClass IITrimix Injectable 30 mg/2 mg/20 mcg, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Lack of Assurance of Sterility
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