Class II · ModerateRecall completed
Orphenadrine Citrate
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: JX6411, JX6413, Exp. 05/2022 Lot #: KC0723,KC3303, Exp. 08/2022 Lot #: KE4348, KE7169,KE4349, Exp. 11/2022 Lot #: KL3199, KM0072,KS3939, Exp. 03/2023 Lot #: LA7704, LA7703,LA9243, Exp. 11/2023
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made bySandoz Inc., Princeton, NJ 08540
| Brand name | ORPHENADRINE CITRATE |
| Generic name | ORPHENADRINE CITRATE |
| Active ingredient(s) | ORPHENADRINE CITRATE |
| Distributed by / for | Sandoz, Inc |
| NDC | 0185-0022-01 |
Show the full FDA record
| Full product label | Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01. |
| Recalling firm | Sandoz, Inc |
| Distribution | Nationwide |
| Quantity | 7908 bottles(790,800 extended release tablets) |
| Recall initiated | 2022-03-21 |
| Report date | 2022-04-13 |
| Recall completed | 2023-08-14 |
| Recall number | D-0753-2022 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Princeton NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.