Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78842

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

Open FDA event record

Event summary

Timeline bucket
January 09, 2017
Product types
Drug
Classifications
Class II
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

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

Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046 INDIA, NDC 43598-611-11

D-0213-2018
Recall number
D-0213-2018
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
1,051 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.

Code information

Lot #: H7044, Exp 05/19

Distribution pattern

Distributed nationwide in the USA, Uzbekistan, and Myanmar