Class I - Dangerous
Failed dissolution specifications: lower than specifications
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Prescription Drugs
💊 Drugs • 11,927 recalls
Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.
The Harvard Drug Group LLC
Class I - Dangerous
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Class I - Dangerous
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Class I - Dangerous
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3.
A-S Medication Solutions
Class I - Dangerous
Presence of Foreign Tablets/Capsules.
Lack of Assurance of Sterility
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.