Recalls / Class III
Class IIID-0899-2023
Product
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
- Brand name
- Amlodipine Besylate
- Generic name
- Amlodipine Besylate
- Active ingredient
- Amlodipine Besylate
- Route
- Oral
- NDCs
- 68180-233, 68180-750, 68180-751, 68180-752, 68180-719, 68180-720, 68180-721, 68180-455
- FDA application
- ANDA078043
- Affected lot / code info
- Lot #: A102887, Exp. 6/2023
Why it was recalled
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 3,096 bottles
- Distribution pattern
- Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
Timeline
- Recall initiated
- 2023-06-27
- FDA classified
- 2023-07-07
- Posted by FDA
- 2023-07-19
- Terminated
- 2024-03-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0899-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.