Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton,
Summary
The FDA issued a Class II for Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, by Sandoz, Inc. Reason: CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit..
Details
Source
Drug Recall
External ID
D-0753-2022
Action Date
2022-04-13
Status
Terminated
Category
drug
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.
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
Quantity Affected: 7908 bottles(790,800 extended release tablets)
Reason for Recall
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-21
Company
Princeton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 47 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Sandoz, Inc has 19 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sandoz, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sandoz, Inc have FDA actions?
Sandoz, Inc has 19 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0753-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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