Exact FDA event identifier

Event 64857

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

Event summary

Timeline bucket: April 08, 2013
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Hi-Tech Pharmacal Co., 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

BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1 Fl. Oz. (30 mL), Manufactured for GIL PHARMACEUTICAL CORP, PONCE, PUERTO RICO 00717-1565 -- NDC 58552-103-01

D-418-2013

Recall number: D-418-2013
Initiated: April 08, 2013
Classification: Class III
Status: Terminated
Recalling firm: Hi-Tech Pharmacal Co., Inc.
Quantity: 10,440 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent; Cetylpyridinum Chloride

Code information

Lot 611614 (exp. 09/2013)

Distribution pattern

Puerto Rico