FDA-Drug2014-07-30Class III
Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.
Sandoz Inc
Hazard
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Sold states
Nationwide
Affected count
781,000 extended release tablets
Manufactured in
506 Carnegie Ctr, Princeton, NJ, United States
Products
Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1445-2014Don't want to check this manually?
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