Class I - Dangerous
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3632-98.
Orient Pharma Co., Ltd. Yunlin Plant
Class I - Dangerous
Failed Impurities/Degradation Specifications.
Class I - Dangerous
Defective container; blister packaging inadequately sealed.
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Thrive Health and Wellness, LLC
Class I - Dangerous
Lack of Assurance of Sterility
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2203-01.
Teva Pharmaceuticals USA
Class I - Dangerous
Presence of foreign tablets/capsules.
Class I - Dangerous
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10
Fresenius Medical Care Holdings
Class I - Dangerous
Lack of Assurance of Sterility
Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Thrive Health and Wellness, LLC
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01
Advanced Pharmaceutical Technology
Class I - Dangerous
Marketed Without an Approved NDA/ANDA
Discoloration; discolored solution from cracked vials
Class I - Dangerous
Lack of Assurance of Sterility
Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Thrive Health and Wellness, LLC
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
Aurobindo Pharma USA
Class I - Dangerous
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Class I - Dangerous
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.
Zydus Pharmaceuticals (USA)
Class I - Dangerous
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
Class I - Dangerous
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.