Why it was recalled
Failed Dissolution Specifications
Product description
Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30.
Lot numbers, UPCs & expiration codes
Lot #: 3126431B, Expiry: 09/30/17
Where it was sold
U.S. Including: FL, LA, MI, MS, NC, NJ, OH and SC.
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-0810-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 31, 2016
- FDA report date
- Apr 13, 2016
- Quantity
- 2172 Cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Purdue Pharma L.P.
Original FDA data
Every field from FDA enforcement report D-0810-2016, exactly as published.
Show all FDA fields
- City
- Stamford
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 73709
- Address
- 201 Tresser Blvd
- Code information
- Lot #: 3126431B, Expiry: 09/30/17
- Postal code
- 06901-3435
- Report date
- Apr 13, 2016
- Product type
- Drugs
- Recall number
- D-0810-2016
- Classification
- Class III
- Recalling firm
- Purdue Pharma L.P.
- Product quantity
- 2172 Cartons
- Termination date
- Apr 12, 2017
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30.
- Distribution pattern
- U.S. Including: FL, LA, MI, MS, NC, NJ, OH and SC.
- Recall initiation date
- Mar 31, 2016
- Initial firm notification
- Letter
- Center classification date
- Apr 4, 2016