Lack of Assurance of Sterility
💊
Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Class I - Dangerous
Presence of foreign substance: Presence of Benzene.
Lack of Assurance of Sterility
Class I - Dangerous
Presence of foreign substance: Presence of Benzene.
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93
MYLAN PHARMACEUTICALS
Class I - Dangerous
Failed Dissolution Specifications - low dissolution results
Class I - Dangerous
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class I - Dangerous
Super-Potent Drug: Out of specification potency results were obtained.
Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04
Slate Run Pharmaceuticals
Class I - Dangerous
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.
One Source Nutrition, Inc,
Class I - Dangerous
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Class I - Dangerous
Super-Potent Drug: Out of specification potency results were obtained.
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04
Slate Run Pharmaceuticals
Class I - Dangerous
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30
Golden State Medical Supply
Class I - Dangerous
Failed Dissolution Specifications
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
Rising Pharma Holding
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class I - Dangerous
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Class I - Dangerous
Presence of foreign tablets/capsules
Class I - Dangerous
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq