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Open, Classified

Stimulen Collagen Moisturizing Lotion, ST9555B

FDA Recall Z-2109-2021 · Posted None

Recalling FirmSouthwest Technologies Inc
Recall StatusOpen, Classified
Product CodeKGN
Date Initiated2021-05-28
Product Quantity2016 units

Reason for Recall

Dose audit failure after sterilization process

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Malaysia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030774STIMULEN COLLAGENSouthwest Technologies, Inc. · 2004-08-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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