Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities.
Drugs Recalls
Prescription and over-the-counter medications
All Sterile Products within expiry
Vital Rx, Inc.
Lack of Assurance of Sterility .
Microbial Contamination of Non-Sterile Products
Microbial Contamination of Non-Sterile Products
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC 42806-263-01, UPC 342806263013
Elite Laboratories
Failed Impurities/Degradation Specifications
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16
International Laboratories
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
Failed Dissolution Specification
Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA, NDC 00093-7772-05
Teva Pharmaceuticals USA
Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Jeedimetla,Hyderabad - 500 055, India, NDC 31722-574-47
Hetero Labs, Ltd. - Unit III
Presence of foreign substance (screw)
Marketed Without an Approved NDA/ANDA
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Failed Dissolution Specifications.
CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 0641-6145-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.
West-Ward Pharmaceuticals
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
GMP Deviations: inadequate manufacturing control processes