Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2019-12-11FDA-DrugFagron, IncClass IILETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium Metabisulfite - 75 mg, SuturaGel Methlcellulose Base; RX Only, For Prescription Compounding, Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120. NDC: 51552-1539-1
Microbial contamination of non-sterile product.
- 2019-12-04FDA-DrugAvantor Performance Materials IncClass IIPotassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical Chemical, packaged in a) 500G glass bottles, product number 3248-01, NDC 10106-3248-1; b) 2.5KG glass bottles, product number 3248-05, NDC 10106-3248-2; c) 12KG pails, product number 3248-07, NDC 10106-3248-3; d) 1KT bottles and drums, product number 3248-X2; e) 1KT bottles and drums, product number 3248-X3; f) 12KG pails, product number 7390-19; Avantor Performance Materials, LLC, 100 Matsonford, Road, Suite 200,
Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
- 2019-12-04FDA-DrugAuroMedics Pharma LLCClass IILidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-165-05.
Presence of Foreign Substance: Foreign material found inside the vial.
- 2019-12-04FDA-DrugPreferred Pharmaceuticals, IncClass IIIbuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA. Mfg: Taro Pharm.; Hawthorne, NY; NDC 68788-7268-01
Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- 2019-12-04FDA-DrugAuroMedics Pharma LLCClass IIAurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
- 2019-12-04FDA-DrugAuroMedics Pharma LLCClass IIRanitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
- 2019-12-04FDA-DrugAuroMedics Pharma LLCClass IIAurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
- 2019-12-04FDA-DrugAuroMedics Pharma LLCClass IIAurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
- 2019-12-04FDA-DrugAuroMedics Pharma LLCClass IIDG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
- 2019-12-04FDA-DrugAVKARE Inc.Class IIAVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- 2019-12-04FDA-DrugAVKARE Inc.Class IIAVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- 2019-12-04FDA-DrugNew Vitalis Pharmacy LLC dba New Vitalis PharmacyClass IITestosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy
Lack of sterility assurance.
- 2019-12-04FDA-DrugAuroMedics Pharma LLCClass IIIAmiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-182-18
Crystallization: Presence of visible particulate matter.
- 2019-12-04FDA-DrugAuroMedics Pharma LLCClass IIIAmiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09
Crystallization: Presence of visible particulate matter.
- 2019-12-04FDA-DrugAuroMedics Pharma LLCClass IIIAmiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-180-03
Crystallization: Presence of visible particulate matter.
- 2019-11-27FDA-DrugX-Gen Pharmaceuticals Inc.Class IIILevetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X-Gen Pharmaceuticals, Inc. Big Flats, NY 14814, NDC 39822-4000-1
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
- 2019-11-27FDA-DrugTeva Pharmaceuticals USA, Inc.Class IIValganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: Actavis Laboratories FL. Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-2579-20
Presence of foreign substance: Brown/black particles found during stability testing.
- 2019-11-27FDA-DrugBaxter Healthcare CorporationClass II0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29
Lack of Assurance of Sterility: Product has the potential to leak.
- 2019-11-27FDA-DrugIntegrated Health Concepts Inc. dba Conversio HealthClass IIAlbuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
Lack of Processing Controls
- 2019-11-27FDA-DrugIntegrated Health Concepts Inc. dba Conversio HealthClass IIAlbuterol 1.25mg / Ipratropium 0.5mg, 2ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
Lack of Processing Controls
- 2019-11-27FDA-DrugIntegrated Health Concepts Inc. dba Conversio HealthClass IIAlbuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
Lack of Processing Controls
- 2019-11-27FDA-DrugIntegrated Health Concepts Inc. dba Conversio HealthClass IIAlbuterol 2.5mg / Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401.
Lack of Processing Controls
- 2019-11-27FDA-DrugIntegrated Health Concepts Inc. dba Conversio HealthClass IIAlbuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg, 3ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401.
Lack of Processing Controls
- 2019-11-27FDA-DrugIntegrated Health Concepts Inc. dba Conversio HealthClass IIAlbuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
Lack of Processing Controls
- 2019-11-27FDA-DrugIntegrated Health Concepts Inc. dba Conversio HealthClass IIAlbuterol 2.5mg / Ipratropium 0.75mg, 2ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
Lack of Processing Controls
- 2019-11-27FDA-DrugIntegrated Health Concepts Inc. dba Conversio HealthClass IIAlbuterol 3.75mg / Ipratropium 0.75mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
Lack of Processing Controls
- 2019-11-27FDA-DrugIntegrated Health Concepts Inc. dba Conversio HealthClass IIBudesonide 0.4mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
Lack of Processing Controls
- 2019-11-27FDA-DrugIntegrated Health Concepts Inc. dba Conversio HealthClass IIFormoterol 12mcg / Budesonide 0.5mg, 3.5ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401.
Lack of Processing Controls
- 2019-11-27FDA-DrugWashington Homeopathic Products, Inc.Class IIR2103, Active Ingredients: Berberis Aquifolium 3x; Borax 3; , Kreosotum 10X; Sepia 3x. Inactive ingredient: 28% dilution alcohol, packaged in a) 470 mL bottle and b) 1000 mL bottle; Manufactured for Wisconsin Pharmacal Company, By: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
CGMP Deviations: products were not manufactured under current good manufacturing practices.
- 2019-11-27FDA-DrugWashington Homeopathic Products, Inc.Class IIStellaLife VEGA Oral Gel Rinse (In equal parts of: Azadirachta Indica 1x, Calendula Officinalis 1x, Echinacea Purpurea 1x, Plantago Major 1x), packaged in 1000 mL white plastic bottle.
CGMP Deviations: products were not manufactured under current good manufacturing practices.
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