Sandoz, Inc recalls Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton,
Recalled April 13, 2022 · FDA recall D-0753-2022 · Sandoz
Hazard
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit. · FDA Class II
Units
7908 bottles(790,800 extended release tablets)
Sold at
Nationwide
Description
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Product
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
Manufacturer(s)
Sandoz, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →