Why it was recalled
Failed dissolution specifications
Product description
Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30
Lot numbers, UPCs & expiration codes
Lot # 3122833A, Expiry 5/31/16
Where it was sold
Nationwide and Puerto Rico
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-1278-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 13, 2015
- FDA report date
- Jul 29, 2015
- Quantity
- 6,264 cartons (30 sublingual tablets in 1 carton)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Purdue Pharma L.P.
Original FDA data
Every field from FDA enforcement report D-1278-2015, exactly as published.
Show all FDA fields
- City
- Stamford
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 71732
- Address
- 201 Tresser Blvd
- Code information
- Lot # 3122833A, Expiry 5/31/16
- Postal code
- 06901-3435
- Report date
- Jul 29, 2015
- Product type
- Drugs
- Recall number
- D-1278-2015
- Classification
- Class III
- Recalling firm
- Purdue Pharma L.P.
- Product quantity
- 6,264 cartons (30 sublingual tablets in 1 carton)
- Termination date
- May 15, 2017
- Reason for recall
- Failed dissolution specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jul 13, 2015
- Initial firm notification
- Letter
- Center classification date
- Jul 21, 2015