FDA recall D-0012-2019

Product

Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159, NDC 69097-128-15

Reason for recall

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

Distribution

Nationwide with the United States

Key facts

Status

Terminated

Initiation date

2018-10-03

Report date

2018-10-17

Termination date

2021-07-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hauppauge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0012-2019