September 6, 2001
Ultra Botanicals recalls MSM Eyes and Nasal Drops Recalled
Los Angeles, CA (SafetyAlerts) - The Food
and Drug Administration (FDA) said today that Ultra Botanicals, Inc. is
recalling MSM Eyes Drops, 1 fl. oz. bottle.
This is the first public notice of
recall issued by the FDA.
PRODUCT AND CODE:
D-289-1 MSM Eyes Drops, 1 fl. oz. The product is an OTC eye and nasal drop
containing methylsulfonylmethane, MSM, packaged under the brand name "UB
Ultra Botanicals MSM Eye Drops". The liquid is packaged in white plastic 1
fluid oz eye drop bottles with a purple label. The product is labeled in
part:"***UB ULTRA BOTANICALS MSM EYE DROPS***1 FLUID OZ***Dosage: Two drops
per eye daily. Use more often for chronic conditions.***Contains: 5% MSM, (methylsulfonyl-methane)
solution in distilled water and .09% saline derived from Natural Sea
Salt.***Exclusively Manufactured For: ULTRA BOTANICALS, Inc. P.O. Box 2266.
Los Angeles, CA 90064***".
All codes and lots.
MICROBIAL CONTAMINATION (Pseudomonas mendocina/Klebsiella pneumoniae)
Allure Cosmetic Inc. Hayward, CA.
Ultra Botanicals, Inc. Los Angeles, CA, by telephone.
FIRM INITIATED RECALL:
AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS,
KY, LA, MA, ME, MI, MD, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK,
OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and Washington, DC.
Three bottles have been sold to a single consignee in Belgium.
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.