Exact FDA event identifier

Event 85231

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

Open FDA event record

Event summary

Timeline bucket: March 16, 2020
Product types: Drug
Classifications: Class I
Statuses: Terminated
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 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540.

D-1094-2020

Recall number: D-1094-2020
Initiated: March 16, 2020
Classification: Class I
Status: Terminated
Recalling firm: Dr. Reddy's Laboratories, Inc.
Quantity: 10943 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective Container: Recall is due to breaking and shattering of ampules upon opening

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Recall is due to breaking and shattering of ampules upon opening

Code information

Lot #: ACB902, ACB903, Exp. Date 03/2021; ACB904, Exp. Date 04/2021, ACB905, Exp. Date 06/2021

Distribution pattern

Nationwide within the United States