Why it was recalled
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Product description
Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA.
Lot numbers, UPCs & expiration codes
Lot #: a) G702755, Exp March 2020; b) G702756, Exp March 2020
Where it was sold
Nationwide in the USA and Puerto Rico.
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-0513-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 13, 2019
- FDA report date
- Feb 27, 2019
- Quantity
- 44,640 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0513-2019, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 82126
- Address
- 111 S Calvert St Fl 21ST
- Code information
- Lot #: a) G702755, Exp March 2020; b) G702756, Exp March 2020
- Postal code
- 21202-6174
- Report date
- Feb 27, 2019
- Product type
- Drugs
- Recall number
- D-0513-2019
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 44,640 bottles
- Termination date
- Oct 6, 2020
- Reason for recall
- CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA.
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Feb 13, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 20, 2019