FDA Drug recall D-0513-2019
Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured…
- FDA Drug
- Class III
- terminated
- Published 2019-02-27
On 2019-02-27 the FDA classified a Class III recall of Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured… by Lupin Pharmaceuticals, 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-0513-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-02-13 |
| Published | 2019-02-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA.
Reason
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Identifiers
| ndc | 68180-467-09 |
|---|---|
| ndc | 68180-467-07 |
| ndc | 68180-467-01 |
| ndc | 68180-467-03 |
| ndc | 68180-467-05 |
| ndc | 68180-468-07 |
| ndc | 68180-468-01 |
| ndc | 68180-468-03 |
| ndc | 68180-468-05 |
| ndc | 68180-468-09 |
| ndc | 68180-469-07 |
| ndc | 68180-469-01 |
| ndc | 68180-469-03 |
| ndc | 68180-469-05 |
| ndc | 68180-469-09 |
| code_info | Lot #: a) G702755, Exp March 2020; b) G702756, Exp March 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-0513-2019%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.