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.
- 2019-11-06FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIChildren's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL), Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-8
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- 2019-11-06FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIIbuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-9
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- 2019-11-06FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIIbuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-8
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- 2019-11-06FDA-DrugArbor Pharmaceuticals Inc.Class IIITestosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose, Rx only, Mfd. for: Wilshire Pharmaceuticals, Inc. Atlanta, GA 30328. NDC 52536-625-01
Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials
- 2019-11-06FDA-DrugAuroMedics Pharma LLCClass IIIRanitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79
CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
- 2019-11-06FDA-DrugAVKARE Inc.Class IIAVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- 2019-11-06FDA-DrugAVKARE Inc.Class IIAVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- 2019-11-06FDA-DrugSandoz IncClass IIIGatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India, NDC 61314-672-25.
Labeling: Incorrect or missing package insert.
- 2019-11-06FDA-DrugSandoz IncClass IIINeomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, NDC 61314-630-06
Labeling: Incorrect or missing package insert.
- 2019-11-06FDA-DrugSandoz IncClass IIIBimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina.
Labeling: Incorrect or missing package insert.
- 2019-11-06FDA-DrugInnoveix Pharmaceuticals IncClass IILyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Lack of Sterility Assurance.
- 2019-11-06FDA-DrugInnoveix Pharmaceuticals IncClass IILyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Lack of Sterility Assurance.
- 2019-11-06FDA-DrugInnoveix Pharmaceuticals IncClass IILyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Lack of Sterility Assurance.
- 2019-11-06FDA-DrugInnoveix Pharmaceuticals IncClass IILyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Lack of Sterility Assurance.
- 2019-11-06FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIEstradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India; Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430.
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
- 2019-11-06FDA-DrugMylan Pharmaceuticals Inc.Class IIPrasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
Failed Dissolution Specification: Low out of specification dissolution results.
- 2019-11-06FDA-DrugNephron Pharmaceuticals Corporation dba Nephron Sterile Compounding CenterClass IIIPF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC 29172, NDC 69374-919-10.
Incorrect labeling: Incorrect or missing lot and/or exp date
- 2019-11-06FDA-DrugApotex Inc.Class IIIAtorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
- 2019-10-30FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIPovidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 85085. NDC 42852-006-20
Lack of sterility assurance.
- 2019-10-30FDA-DrugNephron Pharmaceuticals Corporation dba Nephron Sterile Compounding CenterClass IIdel Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10
Lack of Assurance of Sterility; bags have potential to leak
- 2019-10-30FDA-DrugNephron Pharmaceuticals Corporation dba Nephron Sterile Compounding CenterClass IIAmino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10
Lack of Assurance of Sterility; bags have potential to leak
- 2019-10-30FDA-DrugNephron Pharmaceuticals Corporation dba Nephron Sterile Compounding CenterClass IIPF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-526-20
GMP Deviations: potential glass contamination
- 2019-10-30FDA-DrugNephron Pharmaceuticals Corporation dba Nephron Sterile Compounding CenterClass IIPF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-530-25
GMP Deviations: potential glass contamination
- 2019-10-30FDA-DrugNephron Pharmaceuticals Corporation dba Nephron Sterile Compounding CenterClass IIPF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25
GMP Deviations: potential glass contamination
- 2019-10-23FDA-DrugIngenus Pharmaceuticals LlcClass IILeucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839
Crystallization: Presence of particulate matter identified as API crystallization
- 2019-10-23FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIPantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-284-90
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
- 2019-10-23FDA-DrugAtlas Pharmaceuticals, LLCClass IIAscorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx only, Atlas Pharmaceuticals, LLC, 711 E Carefree Hwy, Suite 107, Phoenix, AZ 85085, NDC 71591-500-50.
Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.
- 2019-10-23FDA-DrugAurobindo Pharma USA Inc.Class IIDextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Salts of a single Entity Amphetamine Product), 20mg, 100-count bottle, RX Only, Distributed by: Aurobindo Pharma USA Inc., Dayton, NJ 08810, NDC 13107-073-01
Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
- 2019-10-23FDA-DrugKVK-Tech, Inc.Class IIIMethylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown, PA 18940, NDC 10702-0163-50.
Presence of Foreign Substance; Fiber particles.
- 2019-10-23FDA-DrugSpectrum Laboratory ProductsClass IIFentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
CGMP Deviations: Received notice from supplier that there is potential glass contamination.
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