March 2022 FDA Recall Orphenadrine Citrate by Sandoz, Inc
D-0753-2022 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Sandoz, Inc on March 21, 2022 for the product Orphenadrine Citrate. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0753-2022

Reason for Recall
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Initiated
03-21-2022
Reported
04-13-2022
Quantity
7908 bottles(790,800 extended release tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88937
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sandoz, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-14-2023
Product Description About Product Description
Full technical description of the product.
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

0185-0022-10 Orphenadrine Citrate
0185-0022-01 Orphenadrine Citrate