Recall: D-0012-2019

Class III - Minor Violations

Class IIIClassification

2018-10-03Initiated

TerminatedStatus

InvaGen Pharmaceuticals, Inc.Firm

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

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

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.