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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79419

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 05, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sagent Pharmaceuticals Inc

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

Complete imported group

Every recalled product in this event

3 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 3

methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-807-05.

D-0586-2018
Recall number
D-0586-2018
Initiated
March 05, 2018
Classification
Class II
Status
Terminated
Quantity
205,370 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

Code information

Lot #: AJM601, Exp. Jul-2018; AJM701, AJM702, Exp. Dec-2018

Distribution pattern

Nationwide in the USA.

drug · product 2 of 3

methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-808-10.

D-0587-2018
Recall number
D-0587-2018
Initiated
March 05, 2018
Classification
Class II
Status
Terminated
Quantity
176,410 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

Code information

Lot #: AJN601, Exp. Jun-2018; AJN701, AJN702, Exp. Dec-2018

Distribution pattern

Nationwide in the USA.

drug · product 3 of 3

methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-810-30.

D-0588-2018
Recall number
D-0588-2018
Initiated
March 05, 2018
Classification
Class II
Status
Terminated
Quantity
48,964 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

Code information

Lot #: AJP701, AJP702, Exp. Dec-2018; AJP601, Exp. Jul-2018; AJP703, Exp. Aug-2019

Distribution pattern

Nationwide in the USA.