Telmisartan and Amlodipine Tablets 80 mg/5 mg recall: Impurity Out of Spec
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
Why was Telmisartan and Amlodipine Tablets 80 mg/5 mg recalled?
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: 201916 Exp. 08/2019; 20092 Exp. 08/2019
- Product
- Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
- Recalling firm
- AVKARE Inc.
- Quantity
- 397 bottles
- Distribution
- AZ, CO
- Recall date
- April 17, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)