Quetiapine Tablets USP 400 mg — Class II drug recall D-0287-2019
Terminated recall by Ascend Laboratories LLC, reported 2018-12-05, distributed nationwide. Presence of Foreign Substance; metal shard found in tablet
| Recall number | D-0287-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories LLC, Parsippany, NJ, United States |
| Recall initiated | 2018-11-14 |
| Classified | 2018-11-28 |
| Reported by FDA | 2018-12-05 |
| Terminated | 2020-03-30 |
| Distributed | Nationwide (US) |
| NDC | 67877-0242, 67877-0242-01, 67877-0242-10, 67877-0242-33, 67877-0242-38, 67877-0245, 67877-0245-01, 67877-0245-33, 67877-0245-38, 67877-0246, 67877-0246-01, 67877-0246-10, 67877-0246-33, 67877-0246-38, 67877-0247, 67877-0247-10, 67877-0247-33, 67877-0247-38, 67877-0247-60, 67877-0248, 67877-0248-01, 67877-0248-10, 67877-0248-33, 67877-0248-38, 67877-0249 and 9 more |
| Lot numbers | 7143908 |
| Expiration dates | 2020-11-20 |
Product
Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 --- NDC 67877-248-01, UPC code: 3 67877-248-01 1
Reason for recall
Presence of Foreign Substance; metal shard found in tablet
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-0287-2019. 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.