D-0012-2019 Class III Terminated
FDA drug recall D-0012-2019 was initiated by InvaGen Pharmaceuticals, Inc. on Oct 3, 2018 and is designated Class III. 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. The recall status is terminated (terminated Jul 13, 2021). Affected quantity: 2880 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 17, 2018
- Initiation Date
- Oct 3, 2018
- Termination Date
- Jul 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2880 bottles
Product Description
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 Pattern
Nationwide with the United States
Code Information
Lot #: GG80218, Exp. 12/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0012-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026