FDAClass IIIOctober 19, 2016

Zenatane recall: Failed Dissolution

ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012…

Why was Zenatane recalled?

Failed Dissolution Specifications

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 # 79KB60205; Exp. 02/18

Product
ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012…
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
3,858 prescription packs (115,680 capsules)
Distribution
nationwide
Recall date
October 19, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls