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.

FDA recall notice · announced August 14, 2019 · American Health Packaging

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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.

Reason for recall

CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.

Notes

Distribution: Nationwide within the USA and Puerto Rico
Lot/code information: Lot #: a) G702705 and b) G702706, Exp. 3/31/2020
Quantity: 14,360 bottles
Status: Terminated
Products in this recall event:
- 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 (D-1584-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.