Why it was recalled
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Product description
Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09
Lot numbers, UPCs & expiration codes
Lot #: G304799, Exp. 4/2016
Where it was sold
US No recalled product was distributed to any foreign consignees by Lupin.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1492-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 19, 2016
- FDA report date
- Sep 14, 2016
- Quantity
- 43,536 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Limited
Original FDA data
Every field from FDA enforcement report D-1492-2016, exactly as published.
Show all FDA fields
- City
- Verna, Salcette, Goa
- Status
- Terminated
- Country
- India
- Event ID
- 74964
- Address
- 15-B, Phase 1A, Verna Industrial Area
- Code information
- Lot #: G304799, Exp. 4/2016
- Report date
- Sep 14, 2016
- Product type
- Drugs
- Recall number
- D-1492-2016
- Classification
- Class III
- Recalling firm
- Lupin Limited
- Product quantity
- 43,536 bottles
- Termination date
- Apr 3, 2017
- Reason for recall
- CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09
- Distribution pattern
- US No recalled product was distributed to any foreign consignees by Lupin.
- Recall initiation date
- Feb 19, 2016
- Initial firm notification
- Center classification date
- Sep 6, 2016