FDAClass IIMay 16, 2018

Kalydeco 150 mg tablet blister recall

Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01

Why was Kalydeco 150 mg tablet blister 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
Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01
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)
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