Exact FDA event identifier

Event 89272

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

Event summary

Timeline bucket: December 21, 2021
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Lohxa, LLC

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

SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24.

D-0377-2022

Recall number: D-0377-2022
Initiated: December 21, 2021
Classification: Class I
Status: Terminated
Recalling firm: Lohxa, LLC
Quantity: 87,840 unit dose cups

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0

Microbial Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non-Sterile Product

Code information

Lot #: AM1115S, Exp. Date 01/2023

Distribution pattern

Product was distributed to one wholesale who further distributed the product nationwide in the USA