Exact FDA event identifier

Event 91441

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

Open FDA event record

Event summary

Timeline bucket: January 05, 2023
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: MACLEODS PHARMA USA, 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

Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-022-08

D-0162-2023

Recall number: D-0162-2023
Initiated: January 05, 2023
Classification: Class III
Status: Terminated
Recalling firm: MACLEODS PHARMA USA, INC
Quantity: 10052 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.

Code information

Lot #: BLF2214A; Exp. 06/2025

Distribution pattern

Nationwide within United States and Puerto Rico.