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Out-of-specification test results obtained for identification testing based on HPTLC analysis.
This recall involves Frieyss infant bath seats. The bath seats are blue plastic with four green suction cups on the bottom. Stickers featuring clouds, a lion, a sun and a squirrel holding two ballons are on the front bar. The seat is about 13 inches wide, 12 inches deep and 8 inches high. The bath seats are advertised as suitable for baby ages 6 months to12 months. A sticker on the packaging states, "(barcode-X002RAO6GV) Baby Shower Chair...Made in China." "Pull rubber tab below to release suction pads from bath" is stamped on the bottom of the bath seat.
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.