Class I - Dangerous
Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
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Prescription Drugs
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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
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
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
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Class I - Dangerous
Failed Dissolution Specifications.
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
Class I - Dangerous
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Columbus, Ohio 43217, NDC 68084-046-01
Amerisource Health Services
Class I - Dangerous
Presence of Foreign Tablets/Capsules.