Orphenadrine Citrate Extended-Release Tablets — Class II drug recall D-0753-2022
Terminated recall by Sandoz, Inc, reported 2022-04-13, distributed nationwide. CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
| Recall number | D-0753-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz, Inc, Princeton, NJ, United States |
| Recall initiated | 2022-03-21 |
| Classified | 2022-04-06 |
| Reported by FDA | 2022-04-13 |
| Terminated | 2023-08-14 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 00185-0022, 00185-0022-01, 00185-0022-10 |
| Lot numbers | JX6411, JX6413, KC0723, KC3303, KE4348, KE4349, KE7169, KL3199, KM0072, KS3939, LA7703, LA7704, LA9243 |
| Expiration dates | 2022-05, 2022-08, 2022-11, 2023-03, 2023-11 |
Product
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
Reason for recall
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0753-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.