OXYCODONE HYDROCHLORIDE Recall D-0358-2022
Description: Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01
OXYCODONE HYDROCHLORIDE Recall D-0358-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0358-2022 |
| Event ID | 89324 |
| Brand | OXYCODONE HYDROCHLORIDE |
| Generic Name | OXYCODONE HYDROCHLORIDE |
| Manufacturer | OXYCODONE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | OXYCODONE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Product Distributed in NY and OH. |
| Quantity | 23,965 100 count bottles |
| Recall Reason | Out-of-specification impurity test result observed at 18-month long term stability time point. |
| Drug Classification | Class III |
| Drug Code Info | 20220112 |
| Product NDC | 43386-430 43386-432 43386-433 |
| Drug UPC | 0343386432011 0343386433018 0343386432059 |
| Recall Initiation Date | 20211229 |
| Report Date | 20220112 |
| Classification Date | 20220105 |
| Address | Harborplace Tower111 S Calvert St Fl 21st Baltimore, MD 21202-6174 United States |
| Recalling Firm | Lupin Pharmaceuticals Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | C1ENJ2TE6C |
| Drug Application Number | ANDA204021 |
| Structured Product Labeling (SPL ID) | af5e7ddc-46ae-dd1d-e053-2a95a90a520c |
| Structured Product Labeling (SPL Set ID) | 801cb437-c189-44f5-83eb-a51c365d8a6b |
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