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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92637

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

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Event summary

Timeline bucket
July 05, 2023
Product types
Drug
Classifications
Class III
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

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

Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by: Sun Pharmaceutical Ind., Inc., NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Ltd., India.

D-0924-2023
Recall number
D-0924-2023
Initiated
July 05, 2023
Classification
Class III
Status
Terminated
Quantity
20,884 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.

Code information

Lot#: a) BAC0334A, Exp 06/2023; BAC0532A, Exp 11/2023 BAD0407A, Exp 08/2024 BAD0425A, Exp 08/2024; b) BAC0335A, Exp 06/2023, BAC0533A, Exp 10/2023, BAD0148A, Exp 03/2024, BAD0320A, Exp 07/2024

Distribution pattern

USA nationwide.

Field note

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