FDA Drug recall D-0893-2023
ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd
- FDA Drug
- Class I
- terminated
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd by The Harvard Drug Group, citing labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0893-2023 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2023-05-31 |
| Published | 2023-06-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | The Harvard Drug Group |
| Distribution | US |
Product
ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500 090 India, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-6269-08
Reason
Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.
Identifiers
| ndc | 0904-6269-08 |
|---|---|
| ndc | 0904-6269-45 |
| ndc | 0904-6270-08 |
| ndc | 0904-6270-45 |
| ndc | 0904-6271-08 |
| ndc | 0904-6271-45 |
| ndc | 0904-6272-08 |
| ndc | 0904-6272-45 |
| code_info | Lot: T04769 Exp. 2024/12 |
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-0893-2023%22
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