Drug 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.
D-1445-2014
Product summary
- Firm
- Sandoz Inc
- Event
- Event 68860
- Status
- Terminated
- Classification
- Class III
- Quantity
- 781,000 extended release tablets
- Official record key
drug-enforcement:D-1445-2014
Official wording
Reason: Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Code information: Lot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification