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cGMP deviations
The FRIGG silicone pacifiers came in two designs: Classic and Daisy. The Classic design consists of a silicone nipple attached to a round plastic shield. The Daisy design consists of a silicone nipple attached to a round scalloped plastic shield. Each design came in two sizes: 0-6 months and 6-18 months. The name "FRIGG" appears in raised letters on the handle of the pacifier shield. The FRIGG silicone pacifiers were sold in over 40 colors.
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
This recall involves Karmas Far's infant bath seats sold and marketed as a 2-in-1 or 3-in-1 booster seat for eating, bathing, and sitting up. The plastic bath seats with a removable tray were sold in the following color schemes: yellow, orange, and white. The 2-in-1 seat measures about 13 inches wide, 17 inches deep and 12 inches high. The 3-in-1 seat measures about 14 inches wide, 18 inches deep and 16 inches high.
Product labeled to be Diet and Zero Sugar in the ingredient statement may contain sugar due to an production error.
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
CGMP Deviations
This recall involves the style Baby Ruffle Romper, the style number 66919 is written on the main label at the neck of the top. It's a 100% cotton romper with ruffles sold in Petal Pink, Golden Hour and Juniper with a polka dot pattern in U.S. sizes from zero months to three years and Euro sizes 50-90. There are metal snaps starting from the neckline to the center of the romper.
This recall involves the Baby Long Sleeve Wiggle Set, the style number 66938 is written on the main label at the neck of the top. Metal snaps are located at the crotch of the top. It's a 100% cotton long-sleeve top and pant set sold in Petal Pink with a pink floral pattern; Golden Hour with black and white polka dots and gold trim; and Navy Blue with a green turtle print and navy trim. The set comes in U.S. sizes from zero months to three years and Euro sizes 50-90.
During an FDA investigation the firm was notified that the product contains undeclared shellfish.
Defective Container: Customer complaints for leaking bottles and dispensing issues.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.