Exact FDA event identifier

Event 86969

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

Event summary

Timeline bucket: December 14, 2020
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: CIPLA

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

Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 NDC 69097-805-40

D-0165-2021

Recall number: D-0165-2021
Initiated: December 14, 2020
Classification: Class II
Status: Terminated
Recalling firm: CIPLA
Quantity: 2151 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

cGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: Vials may not be sealed correctly affecting sterility.

Code information

Lot #: 7S10182A, Ex 9/2021

Distribution pattern

USA Nationwide