Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2426-2010

Reliamed Odor Eliminator Drops (8 oz, 4 oz, 1 oz package sizes)

Biomed Laboratories LLC / initiated 2010-08-16 / Terminated / root cause: manufacturing process

BioMed Laboratories began a recall of Reliamed Odor Eliminator Drops (8 oz, 4 oz, 1 oz package sizes) on . The reason FDA records is "The product may contain the mold Aspergillus ssp". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2426-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Biomed Laboratories LLC
Product
Reliamed Odor Eliminator Drops (8 oz, 4 oz, 1 oz package sizes)
Product code
GDS Bag, Stomal
Reason for recall
The product may contain the mold Aspergillus ssp.
Root cause tag
manufacturing process
FDA root cause
Material/Component Contamination
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.
Quantity in commerce
33,772 Units (27,148 8oz bottles. 3,492 4oz bottles. 3,132 1oz bottles).
Distribution
OH, FL, MI
Product codes and lots
Reliamed Odor Eliminator Drops, 8 oz  Part #ZR8OZED, UPC Code 84216701352 Lots: H09010, M09008, M09011, M09016, N09011, M09020, N09015, N09022, N09023, A10001, E10051, B10018, D10008, E09022.   Reliamed Odor Eliminator Drops, 4 oz  Part #ZR4OZED, UPC Code 84216701652 Lots: H09010, M09006, M09016.   Reliamed Odor Eliminator Drops, 1 oz  Part # ZR1OZED, UPC Code 84216701342 Lots: N09022.