Over-the-Counter

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

cGMP Deviations

cGMP Deviations

cGMP Deviations.

cGMP Deviations.

Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.

Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.