OXYCODONE HYDROCHLORIDE Recall D-0368-2022
Description: Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34
OXYCODONE HYDROCHLORIDE Recall D-0368-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0368-2022 |
| Event ID | 89142 |
| Brand | OXYCODONE HYDROCHLORIDE |
| Generic Name | OXYCODONE HYDROCHLORIDE |
| Manufacturer | OXYCODONE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | OXYCODONE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide USA |
| Quantity | 8184 bottles |
| Recall Reason | Labeling: Missing Label |
| Drug Classification | Class III |
| Drug Code Info | 20220119 |
| Product NDC | 50383-961 |
| Drug UPC | 0350383961345 |
| Recall Initiation Date | 20211203 |
| Report Date | 20220119 |
| Classification Date | 20220113 |
| Address | 1925 W Field Ct Ste 300 Lake Forest, IL 60045-4862 United States |
| Recalling Firm | Akorn, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | C1ENJ2TE6C |
| Drug Application Number | ANDA208817 |
| Structured Product Labeling (SPL ID) | 94697867-1189-4a8d-bf98-19b5de95b909 |
| Structured Product Labeling (SPL Set ID) | bb0767d1-b0f8-4975-bf51-631c9fa1b9bb |
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