ESZOPICLONE Recall D-1174-2022
Description: Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA, NDC 33342-299-07
ESZOPICLONE Recall D-1174-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1174-2022 |
| Event ID | 90444 |
| Brand | ESZOPICLONE |
| Generic Name | ESZOPICLONE |
| Manufacturer | ESZOPICLONE |
| Original Package? | 1 |
| Active Substance | ESZOPICLONE |
| Drug Route | ORAL |
| Distribution | Distributed Nationwide and Puerto Rico. |
| Quantity | 168690 Tablets |
| Recall Reason | Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles. |
| Drug Classification | Class II |
| Drug Code Info | 20220713 |
| Product NDC | 33342-299 33342-300 33342-301 |
| Drug UPC | 0333342299079 0333342300119 0333342301116 |
| Recall Initiation Date | 20220616 |
| Report Date | 20220713 |
| Classification Date | 20220705 |
| Address | 666 Plainsboro Rd Bldg 200 Ste 230 Plainsboro, NJ 08536-0009 United States |
| Recalling Firm | Macleods Pharma Usa Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | UZX80K71OE |
| Drug Application Number | ANDA202929 |
| Structured Product Labeling (SPL ID) | 29150821-8963-45fd-879d-535ca7d6b19b |
| Structured Product Labeling (SPL Set ID) | 12593790-e72f-45b1-8895-987cdd075134 |
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