FDAFDA · Food and drugs·Recall number D-0753-2022
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
Published April 13, 2022 · Recall initiated: March 21, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- ORPHENADRINE CITRATE
- Manufacturer
- Sandoz, Inc
- Distributor
- Nationwide
- Lot
- Lot #: 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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