ORPHENADRINE CITRATE Recall D-0753-2022
Description: Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
ORPHENADRINE CITRATE Recall D-0753-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0753-2022 |
| Event ID | 88937 |
| Brand | ORPHENADRINE CITRATE |
| Generic Name | ORPHENADRINE CITRATE |
| Manufacturer | ORPHENADRINE CITRATE |
| Original Package? | 1 |
| Active Substance | ORPHENADRINE CITRATE |
| Drug Route | ORAL |
| Distribution | Nationwide |
| Quantity | 7908 bottles(790,800 extended release tablets) |
| Recall Reason | CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit. |
| Drug Classification | Class II |
| Drug Code Info | 20220413 |
| Product NDC | 0185-0022 |
| Recall Initiation Date | 20220321 |
| Report Date | 20220413 |
| Classification Date | 20220406 |
| Address | 506 Carnegie Ctr Ste 400 Princeton, NJ 08540-6243 United States |
| Recalling Firm | Sandoz, Inc |
| Initial Notification | Press Release |
| Unique Ingredient Identifier | X0A40N8I4S |
| Drug Application Number | ANDA040327 |
| Structured Product Labeling (SPL ID) | b06a6b24-6a02-4ecf-b43b-ed014f24734f |
| Structured Product Labeling (SPL Set ID) | 239018ff-cec6-46de-ae9d-26c9ec034a32 |
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