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SafetyAlerts
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 this Class I recall issued by the FDA.

RECALL NUMBER, 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***".

CODES:
All codes and lots.

REASON:
MICROBIAL CONTAMINATION (Pseudomonas mendocina/Klebsiella pneumoniae)

MANUFACTURER/RECALLING FIRM:
Allure Cosmetic Inc. Hayward, CA.

RECALLED BY:
Ultra Botanicals, Inc. Los Angeles, CA, by telephone.

FIRM INITIATED RECALL:
Ongoing.

DISTRIBUTION:
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.

QUANTITY:
18,026.

 Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.