FDAFDA · Food and drugs·Recall number D-0012-2019
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
Published October 17, 2018 · Recall initiated: October 3, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AMLODIPINE BESYLATE
- Manufacturer
- InvaGen Pharmaceuticals, Inc.
- Distributor
- Nationwide with the United States
- UPC
- 0369097126056
- Lot
- Lot #: GG80218, Exp. 12/2019
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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