Recalls / Class III
Class IIID-1445-2014
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.
- Brand name
- Orphenadrine Citrate
- Generic name
- Orphenadrine Citrate
- Active ingredient
- Orphenadrine Citrate
- Route
- Oral
- NDC
- 0185-0022
- FDA application
- ANDA040327
- Affected lot / code info
- Lot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16
Why it was recalled
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 506 Carnegie Ctr, Princeton, New Jersey 08540-6243
Distribution
- Quantity
- 781,000 extended release tablets
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-07-11
- FDA classified
- 2014-07-23
- Posted by FDA
- 2014-07-30
- Terminated
- 2017-07-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1445-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.