Class II · Moderate risk Terminated
Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202…
Reason Subpotent Drug
Is Rifampin recalled?
23 FDA recalls mention Rifampin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Rifampin.
Class II · Moderate risk Terminated
Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging…
Reason Failed Impurities/Degradation Specification.
Class II · Moderate risk Terminated
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202…
Reason Subpotent Drug and Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202…
Reason Subpotent Drug and Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed by: Akorn Operating…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Terminated
Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus…
Reason Failed Impurities/Degradations Specifications
Class II · Moderate risk Terminated
Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07…
Reason Failed Impurities/Degradation specifications
Class II · Moderate risk Terminated
Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202…
Reason Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Class II · Moderate risk Terminated
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS…
Reason Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Class II · Moderate risk Terminated
Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60), c)…
Reason Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Class II · Moderate risk Ongoing
Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle…
Reason Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Class II · Moderate risk Ongoing
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC…
Reason Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Class II · Moderate risk Terminated
Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD…
Reason CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Class II · Moderate risk Terminated
Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV…
Reason Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Class II · Moderate risk Terminated
Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC…
Reason Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the…
Class III · Low risk Terminated
RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
Reason Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
Class II · Moderate risk Terminated
Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake…
Reason Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
Class II · Moderate risk Terminated
RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India…
Reason Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Class II · Moderate risk Terminated
Rifampin 25 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control…
Class III · Low risk Terminated
Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually…
Reason Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
Class II · Moderate risk Terminated
Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ…
Reason Subpotent drug: low fill volume in some of the capsules
Class II · Moderate risk Terminated
Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada…
Reason Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with…
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