Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Supply Disruption — Sandoz, Inc (Moderate Risk —
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Supply Disruption — Sandoz, Inc (Moderate Risk — is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets,; Manufacturer: Sandoz
| Drug name | Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, |
|---|---|
| Manufacturer | Sandoz, Inc |
| Recall/Disruption reason | CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit. |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-0753-2022 |
| Initiation date | 20220321 |
| Quantity affected | 7908 bottles(790,800 extended release tablets) |
| Dosage form | Drugs |
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