Recall: D-1584-2019

Class III - Minor Violations

Class IIIClassification

2019-02-19Initiated

TerminatedStatus

American Health PackagingFirm

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

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

Distribution

Nationwide within the USA and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.