Recalls / Class III
Class IIID-1493-2016
Product
Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03
- 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 #: G304677, G304540, G304536, G304537, G304535, G304541, G304545, G304533, G304532, G304539, G304538, G304534, Exp. 4/2016
Why it was recalled
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Recalling firm
- Firm
- Lupin Limited
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 15-B, Phase 1A, Verna Industrial Area, Verna, Salcette, Goa, N/A, India
Distribution
- Quantity
- 11,812 bottles
- Distribution pattern
- US No recalled product was distributed to any foreign consignees by Lupin.
Timeline
- Recall initiated
- 2016-02-19
- FDA classified
- 2016-09-06
- Posted by FDA
- 2016-09-14
- Terminated
- 2017-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1493-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.