Telmisartan and Amlodipine Tablets 80 mg/5 mg recall: Impurity Out of Spec
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured…
Why was Telmisartan and Amlodipine Tablets 80 mg/5 mg recalled?
Failed Impurities/Degradation Specifications; 18 month long term stability study.
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?
G705843 Exp. date April, 2019 G707763 Exp. date August, 2019 G800434 Exp. date November, 2019
- Product
- Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured…
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 12,504 bottles
- Distribution
- Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States.
- Recall date
- April 17, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)