Why it was recalled
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1445-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 11, 2014
- FDA report date
- Jul 30, 2014
- Quantity
- 781,000 extended release tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-1445-2014, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 68860
- Address
- 506 Carnegie Ctr
- Code information
- Lot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16
- Postal code
- 08540-6243
- Report date
- Jul 30, 2014
- Product type
- Drugs
- Recall number
- D-1445-2014
- Classification
- Class III
- Recalling firm
- Sandoz Inc
- Product quantity
- 781,000 extended release tablets
- Termination date
- Jul 10, 2017
- Reason for recall
- Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 11, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 23, 2014