Why it was recalled
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Product description
Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-205-25).
Lot numbers, UPCs & expiration codes
Lot #: 03216026A, Exp. 02/18
Where it was sold
Nationwide within US
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-0608-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 7, 2017
- FDA report date
- Mar 29, 2017
- Quantity
- 11,862 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc
Original FDA data
Every field from FDA enforcement report D-0608-2017, exactly as published.
Show all FDA fields
- City
- Peapack
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76663
- Address
- 100 North Route 206
- Code information
- Lot #: 03216026A, Exp. 02/18
- Postal code
- 07977
- Report date
- Mar 29, 2017
- Product type
- Drugs
- Recall number
- D-0608-2017
- Classification
- Class III
- Recalling firm
- Pfizer Inc
- Product quantity
- 11,862 units
- Termination date
- May 31, 2019
- Reason for recall
- Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-205-25).
- Distribution pattern
- Nationwide within US
- Recall initiation date
- Mar 7, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 22, 2017