🍔 Food 💊 Drugs 🏥 Medical Devices
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 Class II

Reason: Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.

Heritage Pharmaceuticals, Inc. 20150225 Terminated
Distributed: Nationwide
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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 Class II

Reason: Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.

Heritage Pharmaceuticals, Inc. 20150225 Terminated
Distributed: Nationwide
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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 Class II

Reason: Failed Impurities/Degradation Specifications: during long-term stability testing.

Mutual Pharmaceutical Company, Inc. 20150310 Terminated
Distributed: Nationwide
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Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10 Class III

Reason: Subpotent Drug and Failed Impurities/Degradation Specifications

Mylan Institutional LLC 20150123 Terminated
Distributed: Nationwide
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DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 100 mL Multi-Dose Vial, Rx Only, Manufactured By: Onco Therapies Limited, Bangalore, 560105, INDIA, Distributed By: Amneal-Agila, LLC, Glasgow, KY, 42141, NDC 53150-317-01. Class III

Reason: 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

Mylan Institutional LLC 20150211 Terminated
Distributed: Nationwide
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PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONFUL) CONTAINS: Promethazine Hydrochloride 6.25 mg, Dextromethorphan Hydrobromide 15 mg, alcohol 7%, ONE PINT (574 mL), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-1586-58. Class II

Reason: Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.

Qualitest Pharmaceuticals 20150223 Terminated
Distributed: Nationwide
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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. Class II

Reason: Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.

Fusion Pharmaceuticals, LLC 20150306 Terminated
Distributed: California
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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. Class III

Reason: Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

Micro Labs Usa, Inc S 20141204 Terminated
Distributed: Nationwide.
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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. Class III

Reason: Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

Micro Labs Usa, Inc S 20141204 Terminated
Distributed: Nationwide.
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Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,Princeton, NJ 08540 Class III

Reason: Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

Micro Labs Usa, Inc S 20141204 Terminated
Distributed: Nationwide.
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