Recall Z-2109-2021

Southwest Technologies Inc · initiated May 28, 2021

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Stimulen Collagen Moisturizing Lotion, ST9555B

Codes / lots: Lot 2104007, EXP: 02/2024

Reason for recall

Dose audit failure after sterilization process

FDA-determined cause: Under Investigation by firm

Action taken

The firm notified its sold consignee of the issue by telephone on 05/28/2021 of the issue. The firm followed with a letter disseminated by letter on 06/18/2021 requesting that the distributor destroy any product on hand and notify their customers.

Details

Recall number
Z-2109-2021
Initiated
May 28, 2021
Product code
KGN – Wound Dressing With Animal-Derived Material(S)
Quantity
2016 units
Distribution
Malaysia
Recalling firm
Southwest Technologies Inc, Kansas City, MO

Official FDA recall record