FDAClass IIOctober 7, 2020

Buprenorphine Transdermal System 5 mcg/hour recall

Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems…

Why was Buprenorphine Transdermal System 5 mcg/hour recalled?

Failed Stability Specifications: Below specification result for buprenorphine release rate.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 190017, exp. 02/2021; 190161, exp. 08/2021

Product
Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems…
Recalling firm
Teva Pharmaceuticals USA
Quantity
32,543 cartons
Distribution
Nationwide in the U.S. and PR
Recall date
October 7, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls