November 6, 2019DrugsFDA
FITOTERAPIA USA, INC recalls Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (60 mL) bottle, Manufactured By:
Hazard: Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
November 6, 2019DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL), Dis
Hazard: Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
November 6, 2019DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Dis
Hazard: Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
November 6, 2019DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL), Dis
Hazard: Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
November 6, 2019DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Bra
Hazard: Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
November 6, 2019DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., B
Hazard: Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
November 6, 2019DrugsFDA
Arbor Pharmaceuticals Inc. recalls Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose, Rx only, Mfd. for: Wilshire Pharmaceutica
Hazard: 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
November 6, 2019DrugsFDA
AuroMedics Pharma LLC recalls Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN
Hazard: CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
November 6, 2019DrugsFDA
AVKARE Inc. recalls AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for:
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
November 6, 2019DrugsFDA
AVKARE Inc. recalls AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for:
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
November 6, 2019DrugsFDA
Sandoz Inc recalls Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon
Hazard: Labeling: Incorrect or missing package insert.
November 6, 2019DrugsFDA
Sandoz Inc recalls Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured b
Hazard: Labeling: Incorrect or missing package insert.
November 6, 2019DrugsFDA
Sandoz Inc recalls Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC
Hazard: Labeling: Incorrect or missing package insert.
November 6, 2019DrugsFDA
Innoveix Pharmaceuticals Inc recalls Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 750
Hazard: Lack of Sterility Assurance.
November 6, 2019DrugsFDA
Innoveix Pharmaceuticals Inc recalls Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Hazard: Lack of Sterility Assurance.
November 6, 2019DrugsFDA
Innoveix Pharmaceuticals Inc recalls Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 750
Hazard: Lack of Sterility Assurance.
November 6, 2019DrugsFDA
Innoveix Pharmaceuticals Inc recalls Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 8
Hazard: Lack of Sterility Assurance.
November 6, 2019DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (
Hazard: Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
November 6, 2019DrugsFDA
Mylan Pharmaceuticals Inc. recalls Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S
Hazard: Failed Dissolution Specification: Low out of specification dissolution results.
November 6, 2019DrugsFDA
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center recalls PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled
Hazard: Incorrect labeling: Incorrect or missing lot and/or exp date
November 6, 2019DrugsFDA
Apotex Inc. recalls Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Ca
Hazard: Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
October 30, 2019DrugsFDA
Avella of Deer Valley, Inc. Store 38 recalls Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th A
Hazard: Lack of sterility assurance.
October 30, 2019DrugsFDA
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center recalls del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St.
Hazard: Lack of Assurance of Sterility; bags have potential to leak
October 30, 2019DrugsFDA
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center recalls Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Neph
Hazard: Lack of Assurance of Sterility; bags have potential to leak
October 30, 2019DrugsFDA
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center recalls PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 m
Hazard: GMP Deviations: potential glass contamination
October 30, 2019DrugsFDA
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center recalls PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (5
Hazard: GMP Deviations: potential glass contamination
October 30, 2019DrugsFDA
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center recalls PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/
Hazard: GMP Deviations: potential glass contamination
October 23, 2019DrugsFDA
Ingenus Pharmaceuticals Llc recalls Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharm
Hazard: Crystallization: Presence of particulate matter identified as API crystallization
October 23, 2019DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant
Hazard: CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
October 23, 2019DrugsFDA
Atlas Pharmaceuticals, LLC recalls Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx only, Atlas Pharmaceuticals, LLC, 7
Hazard: Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.