Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10
Osmotica Pharmaceutical
Class I - Dangerous
Subpotent Drug
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84
Amneal Pharmaceuticals of New York
Class I - Dangerous
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Class I - Dangerous
Subpotent Drug: found to be below the specification for labeled assay.
Class I - Dangerous
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.
All Sterile Products within expiry
Vital Rx, Inc.
Class I - Dangerous
Lack of Assurance of Sterility .
Class I - Dangerous
Microbial Contamination of Non-Sterile Products
Class I - Dangerous
Microbial Contamination of Non-Sterile Products
Class I - Dangerous
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.
Class I - Dangerous
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Class I - Dangerous
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
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
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
Class I - Dangerous
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
Class I - Dangerous
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
Class I - Dangerous
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
Class I - Dangerous
Presence of foreign substance (screw)
Class I - Dangerous
Marketed Without an Approved NDA/ANDA
Class I - Dangerous
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Class I - Dangerous
Failed Dissolution Specifications.