drugs Class III Updated 2014-07-30

Sandoz Inc recalls Orphenadrine Citrate Extended Release Tablets, 100 mg a)100

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16
View official government recall

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