Exact FDA event identifier

Event 90412

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

Open FDA event record

Event summary

Timeline bucket: June 03, 2022
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: SUN PHARMACEUTICAL INDUSTRIES 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

Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.

D-1176-2022

Recall number: D-1176-2022
Initiated: June 03, 2022
Classification: Class II
Status: Terminated
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Quantity: 27 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations: Manufacturing deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.

Code information

Lots JKX3267A & JKX3686A Exp. Date 08/2022 Lot JKX4700A, Exp Date 10/2022 Lot JKX5727A, Exp date 11/2022

Distribution pattern

nationwide.