Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Safen' simple Ostomy Appliance Deodorant (8 oz , 1 oz package sizes)

FDA Recall Z-2428-2010 · Posted 2010-09-17

Recalling FirmBioMed Laboratories
Recall StatusTerminated
Product CodeGDS
Date Initiated2010-08-16
Date Terminated2011-01-24
Product Quantity22,253 (18,060 8oz bottles. 4,193 1oz bottles)

Reason for Recall

The product may contain the mold Aspergillus ssp.

Firm Action

Biomed Laboratories, Inc. of Garland, TX is conducting a recall of the Reliamed Odor Eliminator Drops, Securi-T Ostomy Deodorant, and the Safe n' Simple (Sn'S) Ostomy Appliance Deodorant. Lots being recalled were distributed between June 9, 2009 though June 28, 2010. Biomed will work with their 3 consignees to inform sub-distributors and down to any firm that keeps the product in stock to have the product removed from further distribution and returned. If there are any questions or concerns, please contact Biomed Laboratories, Inc. at (972) 282-8008 or email them at biomedlabs.net.

Root Cause

Material/Component Contamination

Distribution Pattern

OH, FL, MI

Official Source

View FDA Recall →

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

↑