December 20, 2001Unico Holdings Pediatric Electrolyte Oral
Maintenance Solution Recall Update
- The Food and Drug Administration (FDA) released the following information:
Product is in a translucent plastic bottle with shrink wrapped safety seal
around the twist cap. The labeling is multicolored print on plastic wrapper.
Product is labeled in part: "Good Neighbor Pharmacy*Pediatric Electrolyte
Oral Maintenance Solution*Compare to Pedialyte*1 Liter (33.8 FL OZ)
Unflavored* Ingredients.***”, Recall # F-095-2.
Lot Number 1183U 0817 Expiration 7/03 and 1183U 0900 Expiration 7/03.
Unico Holdings, Inc. Lake Worth, FL., by telephone and fax on 8/31/01. Firm
initiated recall complete.
FDA sample assayed sub-potent for sodium (78.2% and 76.9%)
VOLUME OF PRODUCT IN COMMERCE
363 cases of 8-1 liter containers.
CO, CA, and MS.