Exact FDA event identifier

Event 70097

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

Event summary

Timeline bucket: December 23, 2014
Product types: Food
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Hi-Tech Pharmacal Co., Inc.

Dossier provenance

Source snapshots represented here

openFDA Food 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.

food · product 1 of 1

FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701

F-1380-2015

Recall number: F-1380-2015
Initiated: December 23, 2014
Classification: Class II
Status: Terminated
Recalling firm: Hi-Tech Pharmacal Co., Inc.
Quantity: 581 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.

Code information

Lot 62110, exp. date 04/2015

Distribution pattern

NJ, OH, TX, LA, and Puerto Rico