Exact FDA event identifier

Event 83914

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: October 07, 2019
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Mylan Laboratories Limited (Sterile Products Division)

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.

D-0139-2020

Recall number: D-0139-2020
Initiated: October 07, 2019
Classification: Class II
Status: Terminated
Recalling firm: Mylan Laboratories Limited (Sterile Products Division)
Quantity: 19,165 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.

Code information

Lot: 7008334, Exp April 2020; 7008417, Exp Oct 2020

Distribution pattern

Nationwide in the USA