Tootsie Roll Fruit Chews Lemon Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
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CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
Presence of Particulate Matter: One vial was found to contain a hair.
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.