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.

FDA recall notice · announced July 30, 2014 · Sandoz

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Reason for recall

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

Notes

Distribution: Nationwide
Lot/code information: Lot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16
Quantity: 781,000 extended release tablets
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.