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
Reported: October 17, 2018 Initiated: October 3, 2018 #D-0012-2019
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.
Details
- Recalling Firm
- InvaGen Pharmaceuticals, Inc.
- Units Affected
- 2880 bottles
- Distribution
- Nationwide with the United States
- Location
- Hauppauge, NY
Frequently Asked Questions
What product 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. Recalled by InvaGen Pharmaceuticals, Inc.. Units affected: 2880 bottles.
Why was this product recalled? ▼
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 17, 2018. Severity: Low. Recall number: D-0012-2019.
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