Class I - Dangerous
Subpotent Drug and Failed Impurities/Degradation Specifications
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
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
Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.
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.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed Dissolution Specifications
Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10
Sagent Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05
Sagent Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Subpotent Drug