Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
Drugs Recalls
Prescription and over-the-counter medications
Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1
Taro Pharmaceuticals U.S.A.
Cross contamination with other products: traces of Dapsone were found in the finished product.
Subpotent Drug
Subpotent Drug
VANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025007001
Banner Pharmacy Services
Lack of Assurance of Sterility.
Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025018601
Banner Pharmacy Services
Lack of Assurance of Sterility.
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Subpotent Drug
Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025014801
Banner Pharmacy Services
Lack of Assurance of Sterility.
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11
Becton Dickinson & Company
Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)
fentaNYL citrate 1000 mcg (10 mcg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025011001
Banner Pharmacy Services
Lack of Assurance of Sterility.
Subpotent Drug
OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025000101
Banner Pharmacy Services
Lack of Assurance of Sterility.
Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.