April 25, 2017
Alvogen Inc is voluntarily recalling several lots of 30-mg, 60-mg, and 90-mg nifedipine extended-release tablets due to cross-contamination concerns.
The recalled tablets, which are indicated for the treatment of hypertension, have the following code information:
- 30-mg tablets (NDC 47781-368-01)
- Lot numbers BXH1P22, BXH1P21A, BXH1P21, BXH1P31, and BXH1P21B (expiration date, 11/2017)
- Lot numbers BXH6EL1, BXH66A1, BXH6EN1, BXH6EP1, and BXH6ER1 (expiration date, 06/2018)
- Lot numbers BXH81K1A and BXHBJD1A (expiration date, 10/2018)
- 60-mg tablets (NDC 47781-369-01)
- Lot numbers BXH1P41, BXH1BEE1, BXH1BE2, BXH1BE1B, BXH1BE1A, and BXH1P41A (expiration date, 01/2018)
- Lot numbers BXH81R1, BXHBD41A, BXH5ZR1, and BXH9AL1A (expiration date, 06/2018)
- Lot numbers BXHCUD1A and BXHCUF2A (expiration date, 01/2019)
- 90-mg tablets (NDC 47781-370-01)
- Lot numbers BXH1P51, BXH66D1, BXH1P51A, and BXH5ZS1 (expiration date, 03/2018)
- Lot number BXH1P52 (expiration date, 05/2018)
- Lot numbers BXHBKF1A and BXHB8S1A (expiration date, 10/2018)
The impacted products are packaged in 100-count bottles and were distributed nationwide.
The US Food and Drug Administration (FDA) Enforcement Report for the week of April 12, 2017, lists the reason for the recalls as “Cross Contamination with another product: residual powder found in inlet air duct identified as sorafenib.” Sorafenib is a kinase inhibitor used for the treatment of several different types of cancer.
The recalls were initiated in March and are currently in progress. The FDA gave the recalls Class III designations earlier in April.
—Meredith Edwards White