Cholesterol Atorvastatin Calcium Tablets Recalled Due to Potential Presence of Glass Particles

Forty-one affected lots of Atorvastatin Calcium Tablets (10 mg, 20 mg and 40 mg) which is a solid oral dosage form have been recalled because they may contain very small glass particles resembling a fine grain of sand (less than 1 mm in size).


The probability of an adverse event due to consumption of this product is unlikely but cannot be ruled out. Because of the size of the particles which may be present in the affected lots it is unlikely to cause a significant safety concern. However, the possibility of adverse experiences arising primarily due to physical irritation cannot be ruled out.


The product is used to lower blood cholesterol and is packaged in plastic bottles, as 90 and 500 tablets per bottle. The product is a white colored tablet and can be identified by the imprint RX12 on 10 mg tablets, RX828 on 20 mg tablets and RX829 on 40 mg tablets. The product was distributed in the USA to wholesalers and retailers.


See the Recall