Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30

FDA recall notice · announced April 17, 2019 · Avkare

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30

Reason for recall

Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)

Notes

Distribution: AZ, CO
Lot/code information: Lots: 201916 Exp. 08/2019; 20092 Exp. 08/2019
Quantity: 397 bottles
Status: Terminated
Products in this recall event:
- Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30 (D-1122-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.