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) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories.
Lot numbers, UPCs & expiration codes
Lot #: a) G702705 and b) G702706, Exp. 3/31/2020
Where it was sold
Nationwide within 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-1584-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 19, 2019
- FDA report date
- Aug 14, 2019
- Quantity
- 14,360 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-1584-2019, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 83471
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot #: a) G702705 and b) G702706, Exp. 3/31/2020
- Postal code
- 43217-1188
- Report date
- Aug 14, 2019
- Product type
- Drugs
- Recall number
- D-1584-2019
- Classification
- Class III
- Recalling firm
- American Health Packaging
- Product quantity
- 14,360 bottles
- Termination date
- Sep 9, 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) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories.
- Distribution pattern
- Nationwide within the USA and Puerto Rico
- Recall initiation date
- Feb 19, 2019
- Initial firm notification
- Letter
- Center classification date
- Aug 2, 2019