Drug recall D-1445-2014

Class III Terminated reported Jul 30, 2014

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.

Reason for recall

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

Lots and codes

Lot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16

Recall details

Recalling firm
Sandoz Inc, Princeton, NJ
Quantity
781,000 extended release tablets
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
July 11, 2014
Terminated
July 10, 2017

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