Exact FDA event identifier

Event 90868

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

Event summary

Timeline bucket: September 14, 2022
Product types: Drug
Classifications: Class III
Statuses: Completed
Recalling firm wording: Dr. Reddy's Laboratories, 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

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

Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16

D-0007-2023

Recall number: D-0007-2023
Initiated: September 14, 2022
Classification: Class III
Status: Completed
Recalling firm: Dr. Reddy's Laboratories, Inc.
Quantity: 2,838 ampules

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 Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.

Code information

Lot # ACB101, Exp 03/2023

Distribution pattern

USA nationwide