| Nov 4, 2015 |
Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringe f... |
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes fo... |
Class II |
Pine Pharmaceuticals, LLC |
| Oct 29, 2015 |
HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton,... |
Presence of Particulate Matter |
Class II |
Amerisource Health Services |
| Oct 27, 2015 |
Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topic... |
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr... |
Class II |
Geritrex Corp |
| Oct 27, 2015 |
GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx ... |
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr... |
Class II |
Geritrex Corp |
| Oct 27, 2015 |
Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) ,... |
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr... |
Class II |
Geritrex Corp |
| Oct 27, 2015 |
Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-3... |
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr... |
Class II |
Geritrex Corp |
| Oct 27, 2015 |
Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ... |
Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of... |
Class II |
Steris Corp |
| Oct 19, 2015 |
Hydroxocobalamin 5000IU/mL Injection, Rx, Western Drug Inc. 106 E. Main Stree... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Cantharitus Multi-Mix Prep, Rx, Western Drug Inc. 106 E. Main Street, Springe... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Podophyllum 40% Topical, Rx, Western Drug Inc. 106 E. Main Street, Springervi... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Pyridoxine B6 100mg Inj, Rx, Western Drug Inc. 106 E. Main Street, Springervi... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Dextrose 50% Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Hydroxocobalamin 1mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Spr... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Sermorelin Injection 10mg/10mL,10mg/mL, 20mg/10mL, 9mg/9mL, Rx, Western Drug ... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Marcaine 0.24%/Ethanol 4% Injection, Rx, Western Drug Inc. 106 E. Main Street... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Tri-Mix LOW ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerv... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Calcium Chloride Dihydrate Injection, Rx, Western Drug Inc. 106 E. Main Stree... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Progesterone Cyp Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Glutathione 300 mg/1.5 mL Injection, Rx, Western Drug Inc. 106 E. Main Street... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Dep-Estradiol 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, S... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Benadryl 50mg/2mL Pres-Free Injection, Rx, Western Drug Inc. 106 E. Main Stre... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Triamcin 40mg/mL Susp, Rx, Western Drug Inc. 106 E. Main Street, Springervill... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Furosemide 20 mg/mL svn Sol, Rx, Western Drug Inc. 106 E. Main Street, Spring... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Testosterone Injection 100mg/mL, 200mg/mL, 300mg/mL, Rx, Western Drug Inc. 10... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Tacrolimus 0.03% Opth Oint, Rx, Western Drug Inc. 106 E. Main Street, Springe... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Sal-Acid 60% Plaster Paste, Rx, Western Drug Inc. 106 E. Main Street, Springe... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Tri-Test 1:1:1 300mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, ... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Salicylic Acid Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, ... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Toradol 60mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springer... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
PZI 40 Insulin (Human) Inj, Rx, Western Drug Inc. 106 E. Main Street, Springe... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Glutathione 200 mg/mL SVN Injection, Rx, Western Drug Inc. 106 E. Main Street... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Mupiro/Doxycyc Sinus Rinse, Rx, Western Drug Inc. 106 E. Main Street, Springe... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Sodium Chloride 0.9% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerv... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Super B Complex w/Cyano Inj, Rx, Western Drug Inc. 106 E. Main Street, Spring... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Tev-Tropin (Somatropin) Injection, Rx, Western Drug Inc. 106 E. Main Street, ... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Alcohol4%/Bupivicaine0.5% sol, Rx, Western Drug Inc. 106 E. Main Street, Spr... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Tri-Mix ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Ace-Promazine 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, S... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Heparin 1000 Unit/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Spr... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Squaric Acid 4% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville,... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Ascorbic Acid 500 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, ... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Sodium Bicarbonate 8.4% Inj, Rx, Western Drug Inc. 106 E. Main Street, Spring... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Lidocaine Injection 1% , 2%, Rx, Western Drug Inc. 106 E. Main Street, Spring... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Quad Mix Strong Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville,... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
17-Hydroxyprogesterone 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main ... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Dexpanthanol B5 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Sodium Hydroxide 10% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerv... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Phenylephrine 500mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, ... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
Jessners Dermal Solution, Rx, Western Drug Inc. 106 E. Main Street, Springerv... |
Lack of Assurance of Sterility |
Class II |
Western Drug |
| Oct 19, 2015 |
HCG 10,000U/10mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springe... |
Lack of Assurance of Sterility |
Class II |
Western Drug |