Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failures
Pfizer is recalling 14,712 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 recall is classified as FDA Class III, which indicates a violation of labeling or FDA regulations that is not likely to cause adverse health consequences. The hazard is a quality control failure (dissolution) without reported injuries or illnesses.
Plain-English summary
Pfizer Inc. is recalling 14,712 bottles of Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume. The product is distributed by Nextwave Pharmaceuticals, Inc., a subsidiary of Pfizer Inc., and manufactured by Tris Pharma, Inc. The specific lot affected is # 03216048A with an expiration date of 05/18. The product is distributed nationwide.
The recall was initiated because the product failed dissolution specifications. Dissolution testing ensures that the medication releases the active ingredient at the correct rate and amount. When a product fails these specifications, it may not deliver the intended dose to the patient.
Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- 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
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 14,712
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 (2)
- Lot # 03216048A
- Exp. 05/18
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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