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CGMP deviations: Lack of potency testing.
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Cross contamination: the excipient was found to be contaminated with theophylline.
CCP deviation with the wash process
The firm was notified via a consumer complaint that the product contained a long piece of metal.
Recall due to presence of foreign material. Foreign object is made out of black and hard plastic.
This recall involves three models of Zinus' metal bunk beds. The OPLBB model is a black twin-over-twin bed whose bed posts have a square cross section. The RPBB model is a blue twin-over-twin bed whose bed posts have a circular cross section. The NTBB model is a gray twin-over-full bed whose bed posts have a circular cross section. All models have ladders built into both the head and foot of the bed. The model number is printed on a label on the horizontal bar of the guard rail of the upper bunk.
This recall involves Crafty Bubbles Wintergreen Essential oil in amber 15 mL and 100 mL bottles with a black continuous thread cap. "Crafty Bubbles," "Wintergreen Essential Oil" and the volume amount are printed on the white label on the front of each bottle.
This recall involves the Arena Swim Snorkel Pro II (style 001969) sold in black, acid lime and pink and Swim Snorkel II (style 001970) sold in black and acid lime. Both styles have the "Arena" logo printed on the top of the tube. The style code and production date are printed on the tube above the mouthpiece along with EN 1972 Class A and Made in China. The recall includes the following styles: Style Color Style code Arena Swim Snorkel Pro II Black 001969-501 Acid Lime 001969-605 Pink 001969-905 Swim Snorkel II Black 001970-501 Acid Lime 001970-605
Processing error resulting in mixing of pasteurized and raw cider into final product.
Undeclared sulfites