RecallRadar

FDA Drug recall D-1571-2014

Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd.…

On 2014-10-01 the FDA classified a Class III recall of Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd.… by Akorn, citing failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1571-2014
ClassificationClass III
Statusterminated
Initiated2014-08-05
Published2014-10-01
Last updated2026-09-13 11:51 UTC
CompanyAkorn
DistributionUS

Product

Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for: Akorn, Inc., Lake Forest, IL --- NDC 17478-151-42

Reason

Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point

Identifiers

code_infoLot: 12RIF4A, Expiration Date: 9/30/2014

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1571-2014%22

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