Statin Medication Recall

Several lots of atorvastatin calcium (Lipitor) tablets (10 mg, 20 mg, 40 mg, and 80 mg) are being recalled, the US Food and Drug Administration (FDA) announced in its Enforcement Report for the week of April 5, 2017.

The recalls affect more than 2.4 million bottles and more than 1500 cartons of the prescription statin medication that were distributed throughout the United States and Puerto Rico.

Mylan Pharmaceuticals Inc is voluntarily recalling 90- and 500-count bottles of atorvastatin calcium tablets 10 mg, 20 mg, 40 mg, and 80 mg; and Mylan Institutional Inc (d.b.a. UDL Laboratories) is voluntarily recalling atorvastatin calcium tablets 10 mg, sold as 100-count unit dose tablets (10 x 10) per carton.

The FDA report lists the reason for the recalls as, “Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.”

The code information, including National Drug Codes (NDCs), lot numbers, and expiration dates, for the recalled products are as follows:

• Atorvastatin calcium tablets, 10 mg (1,233,107 bottles recalled)
  • 90-count bottles (NDC 0378-3950-77): lot numbers 3076141 and 3076142 (expiration date, 05/18); lot number 2007223 (expiration date, 06/18); lot number 2007335 (expiration date, 07/18); lot number 2007336 (expiration date, 08/18); lot numbers 2007446 and 3084691 (expiration date, 09/18); and lot number 3084692 (expiration date, 01/18)
  • 90-count bottles (NDC 0378-3950-09): lot number 3073773 (expiration date, 01/18) and lot number 2007445 (expiration date, 09/18)
  • 500-count bottles (NDC 0378-3950-05): lot numbers 3076139, 3076140, and 3076143 (expiration date, 05/18); lot numbers 3076144 and 3076145 (expiration date, 06/18); and lot number 2007445 (expiration date, 09/18)
  • 500-count bottles (NDC 0378-3950-07): lot number 3070837 (expiration date, 10/17); lot number 3073773 (expiration date, 01/18); lot number 3076139 (expiration date, 05/18); lot number 3073774 (expiration date, 01/18); and lot number 2007445 (expiration date, 09/18)
• Atorvastatin calcium tablets, 20 mg (299,112 bottles recalled)
  • 90-count bottles (NDC 0378-3951-09): lot number 3073776 (expiration date, 01/18); lot numbers 3073777 and 3074909 (expiration date, 02/18); lot numbers 3075564 and 3075565 (expiration date, 03/18); and lot number 2007338 (expiration date, 08/18)
  • 500-count bottles (NDC 0378-3951-07): lot number 3070838 (expiration date, 10/17); lot number 3073775 (expiration date, 01/18); lot numbers 3074908 and 3074909 (expiration date, 02/18); lot number 3075564 (expiration date, 03/18); lot numbers 2007224 and 3075887 (expiration date, 06/18); and lot numbers 2007337 and 2007338 (expiration date, 08/18)
• Atorvastatin calcium tablets, 40 mg (444,201 bottles recalled)
  • 90-count bottles (NDC 0378-3952-09): lot numbers 3073779 and 3073780 (expiration date, 02/18); lot number 3074910 (expiration date, 03/18); lot number 3075568 (expiration date, 04/18); lot numbers 3075889 and 3075890 (expiration date, 06/18); lot numbers 2007339 and 2007340 (expiration date, 08/18); and lot numbers 3079881 and 3079882 (expiration date, 10/18)
  • 500-count bottles (NDC 0378-3952-07): lot number 3070839 (expiration date, 10/17); lot numbers 3073778 and 3073779 (expiration date, 02/18); lot numbers 3075566 and 3075567 (expiration date, 04/18); lot numbers 3075890 and 2007225 (expiration date, 06/18); lot number 2007340 (expiration date, 08/18); and lot numbers 3079880 and 3079881 (expiration date, 10/18)
• Atorvastatin calcium tablets, 80 mg (452,269 bottles recalled)
  • 90-count bottles (NDC 0378-3953-09): lot numbers 3073782 and 3073783 (expiration date, 02/18); lot numbers 3074915, 3074916, and 3074917 (expiration date, 03/18); lot numbers 3074918 and 3075572 (expiration date, 04/18); lot numbers 3075573 and 3075574 (expiration date, 05/18); lot numbers 2007226 and 3075894 (expiration date, 06/18); lot numbers 2007344, 2007345, and 2007346 (expiration date, 08/18); and lot numbers 2007451, 2007452, 2007453, and 2007454 (expiration date, 09/18)
  • 500-count bottles (NDC 0378-3953-07): lot number 3070840 (expiration date, 10/17); lot numbers 3073781 and 3074911 (expiration date, 02/18); lot numbers 3074912, 3074913, and 3074914 (expiration date, 03/18); lot numbers 3075570 and 3075571 (expiration date, 04/18); lot number 3075892 (expiration date, 05/18); lot number 3075893 (expiration date, 06/18); lot numbers 2007341, 2007342, 2007343, and 2007347 (expiration date, 08/18); and lot number 2007456 (expiration date, 10/18)
• Atorvastatin calcium tablets, 10 mg (1527 cartons recalled)
  • 100-count unit dose tablets (10 x 10) per carton (NDC 51079-208-20): lot number 3084288 (expiration date, 07/18)

The recalls were initiated on March 20, 2017, and March 21, 2017. They are still in progress. The FDA gave the recalls Class II designations on March 28, 2017.

Atorvastatin calcium tablets have several indications, including to lower the risk of myocardial infarction (MI), stroke, or revascularization procedures and angina in adults who do not have clinically evident coronary heart disease (CHD) but have multiple risk factors for CHD.  

—Meredith Edwards White