Class III
Terminated
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.
This recall has been terminated (originally issued July 30, 2014).
- Company
- Sandoz Inc
- Recall Initiated
- July 11, 2014
- Posted
- July 30, 2014
- Recall Number
- D-1445-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 781,000 extended release tablets
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Distribution
Nationwide
Lot / Code Info
Lot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16
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