FDA Drug recall D-1584-2019
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, Ma…
- FDA Drug
- Class III
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class III recall of 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, Ma… by American Health Packaging, citing CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1584-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-02-19 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | American Health Packaging |
| Distribution | US |
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.
Identifiers
| ndc | 68001-314-00 |
|---|---|
| ndc | 68001-314-08 |
| ndc | 68001-315-00 |
| ndc | 68001-315-08 |
| ndc | 68001-316-00 |
| ndc | 68001-316-08 |
| code_info | Lot #: a) G702705 and b) G702706, Exp. 3/31/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1584-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.