Drug recall D-0753-2022
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.
Lots and codes
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
Recall details
- Recalling firm
- Sandoz, Inc, Princeton, NJ
- Quantity
- 7908 bottles(790,800 extended release tablets)
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 21, 2022
- Terminated
- August 14, 2023
Related products
- Orphenadrine citrate – drug information
- NDC 0185-0022 Orphenadrine Citrate · Orphenadrine Citrate 100 mg/1 · Sandoz Inc