Lovastatin Tablets USP — Class II drug recall D-0222-2018
Terminated recall by AVKARE Inc., reported 2018-01-24, distributed nationwide. Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability te
| Recall number | D-0222-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE Inc., Pulaski, TN, United States |
| Recall initiated | 2018-01-03 |
| Classified | 2018-01-12 |
| Reported by FDA | 2018-01-24 |
| Terminated | 2020-05-08 |
| Distributed | Nationwide (US) |
| Quantity | 237 cartons |
| Reason classes | specification failure |
| NDC | 50268-0512-15 |
| Lot numbers | 01/18, 15270 |
Product
Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.
Reason for recall
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
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-0222-2018. 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.