Orphenadrine Citrate Tablet, Extended Release
FDA Recall NDC 0185-0022
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Orphenadrine Citrate (NDC 0185-0022). A significant event, classified as Class II, was initiated on Mar 21, 2022 by Sandoz Inc. The reported reason for this action was: "CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Mar 21, 2022
Apr 13, 2022
7908 bottles(790,800 extended release tablets)
Recall Profile & Regulatory Data
Event ID
88937
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sandoz, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 14, 2023
Product Description
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
0185-0022-10Product
0185-0022-01Product
Class III Terminated
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Jul 11, 2014
Jul 30, 2014
781,000 extended release tablets
Recall Profile & Regulatory Data
Event ID
68860
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sandoz Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 10, 2017
Product Description
Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.
Batch or Lot Expiration Information
Lot# DM1316; Exp. 05/16
Lot# DM1318; Exp. 05/16
Affected Packages Involved in this Recall
0185-0022-10Product
0185-0022-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
