Class IF-1525-2018

Class I— FDA's most serious classification, issued when there is a reasonable probability that consumption of or exposure to the product will cause serious adverse health consequences or death.

Product

WHITE VEIN Kratom CAPSULES, sold under brand names Kraken Kratom, Phytoextractum, and Soul Speciosa. The capsules are packaged in plastic heat sealed pouches. Each package sold in 28 grams (1 ounce), 56 grams (2 ounces), 112 grams (4 ounces). The varieties under each brand include: Kraken Kratom White Vein Borneo Kratom Capsules Phytoextractum White Maeng Da Thai Capsules Soul Speciosa White Vein Borneo Kratom Capsules

Type: Food
Affected lot / code info: The lot code represents the day packaged. The first four digits are the year, followed by two digits for the month, followed by two digits for the day. LOT 20180216 LOT 20180217 LOT 20180218 LOT 20180219 LOT 20180220 LOT 20180221 LOT 20180222 LOT 20180223 LOT 20180224 LOT 20180225 LOT 20180226 LOT 20180227 LOT 20180228 LOT 20180301 LOT 20180302 LOT 20180303 LOT 20180304 LOT 20180305 LOT 20180306 LOT 20180307 LOT 20180308
Quantity: 1097 packages total

Why it was recalled

Kraken Kratom, Phytoextractum, and Soul Speciosa WHITE VEIN Kratom CAPSULES are recalled due to potential contamination with Salmonella.

Recalling firm

Firm: Pdx Aromatics
Notification channel: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type: Voluntary: Firm initiated
Address: 2170 N Lewis Ave Ste 250, N/A, Portland, Oregon 97227-1708

Distribution

Distribution pattern: distributed throughout the U.S.

Timeline

Recall initiated: 2018-03-09
FDA classified: 2018-06-04
Posted by FDA: 2018-03-28
Terminated: 2018-09-13
Status: Terminated

Source: openFDA Food Enforcement endpoint. Recall record F-1525-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings.