FDAFDA · Food and drugs·Recall number D-1445-2014
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.
Published July 30, 2014 · Recall initiated: July 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ORPHENADRINE CITRATE
- Manufacturer
- Sandoz Inc
- Distributor
- Nationwide
- Lot
- Lot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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