FDA Drug recall D-0287-2019
Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India
- FDA Drug
- Class II
- terminated
- Published 2018-12-05
On 2018-12-05 the FDA classified a Class II recall of Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India by Ascend Laboratories, citing presence of Foreign Substance; metal shard found in tablet.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0287-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-14 |
| Published | 2018-12-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascend Laboratories |
| Distribution | US |
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
Presence of Foreign Substance; metal shard found in tablet
Identifiers
| upc | 367877248011 |
|---|---|
| ndc | 67877-242-01 |
| ndc | 67877-242-10 |
| ndc | 67877-242-38 |
| ndc | 67877-242-33 |
| ndc | 67877-249-01 |
| ndc | 67877-249-10 |
| ndc | 67877-249-38 |
| ndc | 67877-249-33 |
| ndc | 67877-250-01 |
| ndc | 67877-250-38 |
| ndc | 67877-250-33 |
| ndc | 67877-250-10 |
| ndc | 67877-245-01 |
| ndc | 67877-245-38 |
| ndc | 67877-245-33 |
| ndc | 67877-246-01 |
| ndc | 67877-246-38 |
| ndc | 67877-246-33 |
| ndc | 67877-246-10 |
| ndc | 67877-247-60 |
| ndc | 67877-247-38 |
| ndc | 67877-247-33 |
| ndc | 67877-247-10 |
| ndc | 67877-248-01 |
| ndc | 67877-248-38 |
| ndc | 67877-248-33 |
| ndc | 67877-248-10 |
| code_info | Lot 7143908, exp Nov 2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Ascend Laboratories
- Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laborator…
FDA Drug · Class III · 2026-08-05 · Ascend Laboratories - Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratorie…
FDA Drug · Class III · 2026-08-05 · Ascend Laboratories - Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratori…
FDA Drug · Class III · 2026-08-05 · Ascend Laboratories - Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA
FDA Drug · Class II · 2026-07-29 · Ascend Laboratories - Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by:…
FDA Drug · Class III · 2026-07-29 · Ascend Laboratories
All Ascend Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0287-2019%22
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