FDAClass IIMay 16, 2018

Orkambi 100 mg/125 mg Tablets #112 recall

Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply.

Why was Orkambi 100 mg/125 mg Tablets #112 recalled?

Lack of Processing Controls.

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?

All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018

Product
Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply.
Recalling firm
Kroger Specialty Pharmacy, Inc.
Quantity
Unknown
Distribution
MS, LA, AR, IL, FL
Recall date
May 16, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls