Class II
Terminated
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
- Company
- Sandoz Inc
- Recall Initiated
- March 21, 2022
- Posted
- April 13, 2022
- Recall Number
- D-0753-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 7908 bottles(790,800 extended release tablets)
- Firm Location
- Princeton, NJ, United States
Reason for Recall
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Distribution
Nationwide
Lot / Code Info
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
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