September 20, 2017DrugsFDA
Andropharm, LLC recalls ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packaged in 60-count bottle, Amazon.com
Hazard: Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
September 20, 2017DrugsFDA
Andropharm, LLC recalls ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and 17b-hydroxy-2a, 17b-dimethyl-5a-androstan-
Hazard: Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
September 20, 2017DrugsFDA
Centurion Labs, LLC recalls Ninjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (4
Hazard: Microbial contamination of Non-sterile Products; potential B. cepacia contamination
September 20, 2017DrugsFDA
Centurion Labs, LLC recalls Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Fla
Hazard: Microbial contamination of Non-sterile Products; potential B. cepacia contamination
September 20, 2017DrugsFDA
VistaPharm, Inc. recalls Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx onl
Hazard: Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
September 20, 2017DrugsFDA
MEDLINE INDUSTRIES INC recalls Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g), Manufactured for Medline Industries, Inc
Hazard: Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. The boxes and outer case are correctly labeled as A&D ointment.
September 20, 2017DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distri
Hazard: Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
September 20, 2017DrugsFDA
Mid Valley Pharmaceutical recalls Doctor Manzanilla Cough & Cold (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg i
Hazard: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
September 20, 2017DrugsFDA
Mid Valley Pharmaceutical recalls Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup,
Hazard: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
September 20, 2017DrugsFDA
Ascend Laboratories LLC recalls AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 4
Hazard: PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
September 13, 2017DrugsFDA
ImprimisRx CA, Inc., dba ImprimisRx recalls Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a l
Hazard: Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
September 13, 2017DrugsFDA
ImprimisRx CA, Inc., dba ImprimisRx recalls Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed profession
Hazard: Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
September 13, 2017DrugsFDA
ImprimisRx CA, Inc., dba ImprimisRx recalls Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compounded for a licensed professional or pati
Hazard: Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
September 13, 2017DrugsFDA
ImprimisRx CA, Inc., dba ImprimisRx recalls Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Slow IV Administration, Compounded for a lice
Hazard: Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
September 13, 2017DrugsFDA
Degasa Sa De Cv recalls Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Manufactured for PSS World Medical, Inc. Sout
Hazard: Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
September 13, 2017DrugsFDA
Mckesson Packaging Services recalls Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured By
Hazard: Failed moisture limits: Out of specification for moisture content.
September 13, 2017DrugsFDA
Lupin Pharmaceuticals Inc. recalls Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Ba
Hazard: CGMP Deviations
September 6, 2017DrugsFDA
Tris Pharma Inc. recalls Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syring
Hazard: Defective container: Oral solution leaking from container.
September 6, 2017DrugsFDA
Morton Grove Pharmaceuticals, Inc. recalls Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle
Hazard: Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
September 6, 2017DrugsFDA
Amphastar Pharmaceuticals, Inc. recalls Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals,
Hazard: Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
August 30, 2017DrugsFDA
The Harvard Drug Group recalls Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by:
Hazard: Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
August 30, 2017DrugsFDA
The Harvard Drug Group recalls Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugb
Hazard: Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
August 30, 2017DrugsFDA
The Harvard Drug Group recalls Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Phar
Hazard: Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
August 30, 2017DrugsFDA
The Harvard Drug Group recalls Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by:
Hazard: Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
August 30, 2017DrugsFDA
The Harvard Drug Group recalls Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by:
Hazard: Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
August 30, 2017DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count
Hazard: Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
August 30, 2017DrugsFDA
Brian P. Richardson recalls CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading -- UPC: 95
Hazard: Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk
August 30, 2017DrugsFDA
C. O. Truxton recalls Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown,
Hazard: Labeling: Label Mixup; potentially mislabeled
August 30, 2017DrugsFDA
C. O. Truxton recalls Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsvill
Hazard: Labeling: Label Mixup; potentially mislabeled
August 30, 2017DrugsFDA
C. O. Truxton recalls Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), Rx
Hazard: Labeling: Label Mixup; potentially mislabeled