Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Prescription Drugs
π Drugs β’ 12,141 recalls
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide
Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.
Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/Sterile Syringes, for use by a licensed professional only, not for resale, MD Custom Rx, 19035 W Capitol Dr Ste 105, Brookfield, WI 53045.
Brookfield Prescription Center
Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.
JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle
Dolphin Intertrade
Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309
Fossil Fuel Products
Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.
Presence of Foriegn Tablets/Capsules: A single TikosynΒΏ (dofetilide) 250 mcg capsule was discovered in one bottle of TikosynΒΏ (dofetilide) 500 mcg (0.5 mg).
Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Upsher-Smith Labs, Minneapolis, MN 55447, by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 0245-0272-06
Upsher Smith Laboratories
Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.
VPRIVΒΏ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human Genetic Therapies, Inc. 300 Shire Way, Lexington, MA 02421. NDC: 54092-701-04.
Shire Human Genetic Therapies
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box
Dolphin Intertrade
Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., Lake Forest, IL 60045.
Hospira
Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.
Slim Expert softgel capsules Dietary Supplement. One month supply/ 30 softgels. 1 softgel - 650 mg.
B @ B Trade
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Magic Slim capsules (Ling Zhi, Ebony, Fox-nut, Tuckahoe, Seman Pruni, Dioscoreae, Wheat Germ, Nature Substance), 60-count bottles.
Slim Beauty USA
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.
Penicillin Cross Contamination