Pfizer Recalls Quillivant XR Methylphenidate Suspension Due to Dissolution Failure
Pfizer is recalling 11,790 bottles of Quillivant XR methylphenidate extended-release oral suspension because the product failed dissolution specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Pfizer Inc. is recalling 11,790 bottles of Quillivant XR methylphenidate HCl, for extended-release oral suspension. The affected product is distributed by Nextwave Pharmaceuticals, Inc., a subsidiary of Pfizer Inc., and manufactured by Tris Pharma, Inc. The specific lot number is 03216047A with an expiration date of 02/18.
The recall was initiated because the product failed dissolution specifications. This means the medication may not release the active ingredient at the intended rate, potentially affecting its therapeutic performance. The recall is classified as Class III by the FDA, indicating that the violation is not likely to cause adverse health consequences.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL total volume (When constituted with 131 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 1
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 11,790
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 03216047A Exp. 02/18
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Pfizer Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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