Reported Jul 30, 2014 · Terminated
Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC…
Sandoz Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sandoz Inc · 506 Carnegie Ctr · Princeton, NJ · 08540-6243
Is this the product you have?
- 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.
- Lot codes and dates
Lot # DM1316Exp. 05/16 Lot # DM1318Exp. 05/16
- Amount recalled
- 781,000 extended release tablets
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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