Why it was recalled
Failed Dissolution Specifications
Product description
Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted with 105 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, 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 24478-200-20.
Lot numbers, UPCs & expiration codes
Lot # 03216048A, Exp. 05/18
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-1163-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 4, 2017
- FDA report date
- Sep 27, 2017
- Quantity
- 14,712 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1163-2017, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 77862
- Address
- 235 E 42nd St
- Code information
- Lot # 03216048A, Exp. 05/18
- Postal code
- 10017-5703
- Report date
- Sep 27, 2017
- Product type
- Drugs
- Recall number
- D-1163-2017
- Classification
- Class III
- Recalling firm
- Pfizer Inc.
- Product quantity
- 14,712 bottles
- Termination date
- Apr 11, 2019
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted with 105 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, 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 24478-200-20.
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 4, 2017
- Initial firm notification
- Letter
- Center classification date
- Sep 15, 2017