Agency classClass IIIOur severity:Low FDA (Drugs)·D-1163-2017·Announced 2017-09-27

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.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

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: dissolution-failure
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.

See all 2 products in this recall →

Same manufacturer · Pfizer Inc.

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