HYDROXYAMPHETAMINE HYDROBROMIDE Recall D-0152-2023
Description: PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-704-12
HYDROXYAMPHETAMINE HYDROBROMIDE Recall D-0152-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0152-2023 |
| Event ID | 90948 |
| Brand | PAREMYD |
| Generic Name | HYDROXYAMPHETAMINE HYDROBROMIDE, TROPICAMIDE |
| Manufacturer | HYDROXYAMPHETAMINE HYDROBROMIDE, TROPICAMIDE |
| Original Package? | 1 |
| Active Substance | HYDROXYAMPHETAMINE HYDROBROMIDE TROPICAMIDE |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide in the USA |
| Quantity | 51,601 bottles |
| Recall Reason | CGMP Deviations: |
| Drug Classification | Class II |
| Drug Code Info | 20230125 |
| Product NDC | 17478-704 |
| Product NUI | N0000175574 N0000175370 |
| Drug UPC | 0317478704126 |
| Pharma Class (EPC) | Anticholinergic [EPC] |
| Recall Initiation Date | 20221013 |
| Report Date | 20230125 |
| Classification Date | 20230113 |
| Address | 5605 Centerpoint Ct Ste A Gurnee, IL 60031-5278 United States |
| Recalling Firm | Akorn, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 59IG47SZ0E N0A3Z5XTC6 |
| Drug Application Number | NDA019261 |
| Structured Product Labeling (SPL ID) | 4984db98-48c3-4a2e-b39a-c7475bb2f233 |
| Structured Product Labeling (SPL Set ID) | da8a8a19-ac1b-4160-aac4-c4c57598eb5d |
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