Sandoz Inc recalls Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (ND

Recalled July 30, 2014 · FDA recall D-1445-2014 · Sandoz

Hazard

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing. · FDA Class III

Units

781,000 extended release tablets

Sold at

Nationwide

Description

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

Product

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.

Manufacturer(s)

Sandoz Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →