Lovastatin Tablets USP — Class III drug recall D-1584-2019
Terminated recall by American Health Packaging, reported 2019-08-14, distributed nationwide. CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for indivi
| Recall number | D-1584-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Health Packaging, Columbus, OH, United States |
| Recall initiated | 2019-02-19 |
| Classified | 2019-08-02 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2020-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 14,360 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 68001-0314, 68001-0314-00, 68001-0314-08, 68001-0315, 68001-0315-00, 68001-0315-08, 68001-0316, 68001-0316-00, 68001-0316-08 |
| Expiration dates | 2020-03-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1584-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.