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Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by P...

FDA Recall #D-0810-2016 — Class III — March 31, 2016

Recall #D-0810-2016 Date: March 31, 2016 Classification: Class III Status: Terminated

Product Description

Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30.

Reason for Recall

Failed Dissolution Specifications

Recalling Firm

Purdue Pharma L.P. — Stamford, CT

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

2172 Cartons

Distribution

U.S. Including: FL, LA, MI, MS, NC, NJ, OH and SC.

Code Information

Lot #: 3126431B, Expiry: 09/30/17

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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