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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83315

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

Open FDA event record

Event summary

Timeline bucket
July 10, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
LNK International, 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

Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 8113117595 1

D-1630-2019
Recall number
D-1630-2019
Initiated
July 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
LNK International, Inc.
Quantity
P300456, P300475 and P300489 (Total - 13,500 liters) and P300482 - 3,600 liter

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 #: P300456, P300475,P300482, P300489, Exp 09/30/2020

Distribution pattern

USA Nationwide