Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03
Reported: July 19, 2023 Initiated: June 27, 2023 #D-0899-2023
Product Description
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03
Reason for Recall
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 3,096 bottles
- Distribution
- Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 3,096 bottles.
Why was this product recalled? ▼
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 19, 2023. Severity: Low. Recall number: D-0899-2023.
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