Thousands of Cholesterol Drug Tablets Recalled

Apotex announced a nationwide voluntary recall of Atorvastatin Calcium Tablets 10mg (22,000 tablets), Atorvastatin Calcium Tablets 20mg (7,400 tablets), Atorvastatin Calcium Tablets 40mg (17,200 tablets), and Atorvastatin Calcium Tablets 80mg (16,800 tablets) due to failed impurities/degradation specifications.

The recalled products, supplied by Golden State Medical Supply Inc. and manufactured in their Toronto, Ontario, Canada facility, contain 10 tablets per blister in 100-count packages and have the following specifications:

• Lot #GS005602; Exp. 10/15
• Lot #GS008855; Exp. 09/17
• Lot #GS009074; Exp. 08/17
• Lot #GS009393; Exp. 08/17
• Lot #GS009760; Exp. 10/17
• Lot #GS010599; Exp. 11/17
• Lot #GS008856; Exp. 09/17
• Lot #GS010268; Exp. 09/17
• Lot #GS010600; Exp. 11/17
• Lot #GS009075; Exp. 09/17
• Lot #GS009763; Exp. 09/17
• Lot #GS010178; Exp. 10/17
• Lot #GS005603; Exp. 10/15
• Lot #GS006691; Exp. 08/17
• Lot #GS009073; Exp. 08/17
• Lot #GS009395; Exp. 08/17
• Lot #GS009764; Exp. 10/17

The recall for the aforementioned products was initiated on January 27, 2016. The Food and Drug Administration (FDA) issued a warning letter to Apotex in 2015 for 2 plants in Bangalore, India citing manipulation of test data by the facilities. This practice was said to have persisted for years. Apotex had also received letters from the FDA in 2013 and 2014 regarding violations of current good manufacturing practice (CGMP) regulations in their manufacturing facility in Canada.

Atorvastatin Calcium, the generic of Pfizer’s Lipitor, is an HMG-CoA reductase inhibitor indicated for various hyperlipoproteinemias.

For more information call (800) 706-5575 or visit Apotex.com.