InvaGen Pharmaceuticals, Inc. recalls Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manu…
- Recall date
- October 3, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0012-2019
- FDA classification
- Class III
- Brand / firm
- InvaGen Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide with the United States
Why it was recalled
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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