Exact FDA event identifier

Event 79640

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

Event summary

Timeline bucket: March 19, 2018
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Lake Erie Medical & Surgical Supply 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

Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Quality Care Products, Temperance, MI 48182 Mfr. CSPC Ouyl Pharm Co., Ltd. Shijazhuang, Hebei, China; NDC 55700-0412-01

D-0626-2018

Recall number: D-0626-2018
Initiated: March 19, 2018
Classification: Class III
Status: Terminated
Recalling firm: Lake Erie Medical & Surgical Supply Inc
Quantity: 16 paper cartons

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date

Code information

Lot # 116289, Exp. 09/20

Distribution pattern

FL, VA