FDAClass IIIOctober 17, 2018

Amlodipine Besylate USP 10 mg Tablets recall: Subpotent

Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc.…

Why was Amlodipine Besylate USP 10 mg Tablets recalled?

Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.

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?

Lot #: GG80218, Exp. 12/2019

Product
Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc.…
Recalling firm
InvaGen Pharmaceuticals, Inc.
Quantity
2880 bottles
Distribution
Nationwide with the United States
Recall date
October 17, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls