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Statin Recalled for Impurities


March 11, 2021

Dr. Reddy's Laboratories Inc. is voluntarily recalling more than 235,000 bottles of atorvastatin calcium tablets over impurities, according to the March 10, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects atorvastatin calcium tablets, 40 mg, manufactured by Dr. Reddy's Laboratories Limited, Srikakulam, India, and packaged in:

  • 90-count bottles (NDC 55111-123-90), from lot T900406 (Exp. 3/21); and
  • 500-count bottles (NDC 55111-123-05), from lots T000078 (Exp. 12/21), T000079 (Exp. 12/21), T000080 (Exp. 12/21), T000081 (Exp. 12/21), T000082 (Exp. 12/21), T000083 (Exp. 12/21), T000084 (Exp. 12/21), T000085 (Exp. 12/21), T000086 (Exp. 12/21), T000087 (Exp. 12/21), T000088 (Exp. 1/22), T000311 (Exp. 1/22), T000312 (Exp. 1/22), T000313 (Exp. 1/22), T000314 (Exp. 1/22), T000315 (Exp. 1/22), T000316 (Exp. 1/22), T000317 (Exp. 1/22), T000318 (Exp. 1/22), T000319 (Exp. 1/22), T000320 (Exp. 1/22), T000500 (Exp. 2/22), T000501 (Exp. 2/22), T000502 (Exp. 2/22), T000503 (Exp. 2/22), T000504 (Exp. 2/22), T000505 (Exp. 2/22), T000506 (Exp. 2/22), T000507 (Exp. 2/22), T000508 (Exp. 2/22), T000509 (Exp. 3/22), T000510 (Exp. 3/22), T000647 (Exp. 3/22), T000648 (Exp. 3/22), T000651(Exp. 3/22), T000652 (Exp. 3/22), T000653 (Exp. 3/22), T000654 (Exp. 3/22), T000875 (Exp. 4/22), T000876 (Exp. 4/22), T000877 (Exp. 4/22), T000878 (Exp. 4/22), T000879 (Exp. 4/22), T000880 (Exp. 4/22), T000881 (Exp. 4/22), T000882 (Exp. 4/22), T000883 (Exp. 4/22), T000884 (Exp. 4/22), T001120 (Exp. 5/22), T001121 (Exp. 5/22), T001122 (Exp. 5/22), T001124 (Exp. 5/22), T001125 (Exp. 5/22), T001126 (Exp. 5/22), T001127 (Exp. 5/22), T001128 (Exp. 5/22), T001129 (Exp. 5/22), T001130 (Exp. 5/22), T001260 (Exp. 5/22), T001261 (Exp. 5/22), T900506 (Exp. 4/21), T900507 (Exp. 4/21), T900508 (Exp. 4/21), T900655 (Exp. 5/21), T900656 (Exp. 5/21), T900657 (Exp. 5/21), T900658 (Exp. 5/21), T900659 (Exp. 5/21), T900673 (Exp. 5/21), T900674 (Exp. 5/21), T901024 (Exp. 7/21), T901025 (Exp. 7/21), T901026 (Exp. 7/21), T901027 (Exp. 7/21), T901029 (Exp. 7/21), T901030 (Exp. 7/21), T901031 (Exp. 7/21), T901032 (Exp. 7/21), T901033 (Exp. 7/21), T901424 (Exp. 10/21), T901425 (Exp. 10/21), T901426 (Exp. 10/21), T901427 (Exp. 10/21), T901428 (Exp. 10/21), T901429 (Exp. 10/21), T901430 (Exp. 10/21), T901431 (Exp. 10/21), T901432 (Exp. 10/21), T901433 (Exp. 10/21), T901568 (Exp. 10/21), T901569 (Exp. 10/21), T901570 (Exp. 11/21), T901571 (Exp. 11/21), T901572 (Exp. 11/21), T901573 (Exp. 11/21), T901574 (Exp. 11/21), T901575 (Exp. 11/21), T901576 (Exp. 11/21), and T901577 (Exp. 11/21). 

The affected products were distributed throughout the United States.

Dr. Reddy's Laboratories initiated the recall February 19, 2021. The FDA designated the recall Class III on March 1, 2021, communicating use of the recalled tablets is not likely to cause harm. 

Atorvastatin is a prescription statin used to treat high cholesterol and triglyceride levels.

Jolynn Tumolo

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