Recall: D-0753-2022

Class II - Potentially Harmful

Class IIClassification

2022-03-21Initiated

TerminatedStatus

Sandoz, IncFirm

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

CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.