FDA-Drug2022-04-13Class II
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
Sandoz, Inc
Hazard
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Sold states
Nationwide
Affected count
7908 bottles(790,800 extended release tablets)
Manufactured in
506 Carnegie Ctr Ste 400, Princeton, NJ, United States
Products
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0753-2022Don't want to check this manually?
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