Failed Impurities/Degradation Specification; out of specification results for carbon dioxide
💊
Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Class I - Dangerous
Lack of Assurance of Sterility; due to leaking vials
Class I - Dangerous
Lack of Assurance of Sterility; due to leaking vials
Class I - Dangerous
Failed Impurities/Degradation Specifications; 12 month stability testing.
Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27
American Specialty Pharmacy
Class I - Dangerous
Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product
Class I - Dangerous
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional Consulting, Inc.599 West 190th Street, Suite #1 NYC, NY 10040.
Bethel Nutritional Consulting
Class I - Dangerous
Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss
Class I - Dangerous
Subpotent Drug and Failed Impurities/Degradation Specifications
Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by MUTUAL PHARMACEUTICAL CO., INC., PHILADELPHIA, PA 19124 USA for Sun Pharmaceutical Industries, Inc. 270 Prospect Plains Road, Cranbury, NJ 08512. NDC 53489-281-01
Mutual Pharmaceutical Company
Class I - Dangerous
Failed Impurities/Degradation Specifications: during long-term stability testing.
Class I - Dangerous
Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
Class I - Dangerous
Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL
Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc. NDC 23155-193-31
Heritage Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724 NDC 23155-340-31
Heritage Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-0040-90.
Micro Labs Usa, Inc S
Class I - Dangerous
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90.
Micro Labs Usa, Inc S
Class I - Dangerous
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. Fusion Pharmaceuticals LLC., 768 Calle Plano, Camarillo, CA 93012. NDC: 43093-104-01.
Fusion Pharmaceuticals
Class I - Dangerous
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Class I - Dangerous
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.