Reported Apr 13, 2022 · Terminated
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc.,…
Sandoz, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sandoz, Inc · 506 Carnegie Ctr Ste 400 · Princeton, NJ · 08540-6243
Is this the product you have?
- Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
- Lot codes and dates
Lot #: JX6411JX6413Exp. 05/2022 Lot #: KC0723KC3303Exp. 08/2022 Lot #: KE4348KE7169KE4349Exp. 11/2022 Lot #: KL3199KM0072KS3939Exp. 03/2023 Lot #: LA7704LA7703LA9243Exp. 11/2023
- Amount recalled
- 7908 bottles(790,800 extended release tablets)
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
This product could cause temporary or reversible health problems — stop using it.
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