FDAClass IIMarch 15, 2017

Mirtazapine Tablets recall

Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20

Why was Mirtazapine Tablets recalled?

Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled

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?

Batch #3083289; Exp. Date 12/2018

Product
Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20
Recalling firm
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Quantity
58 UD100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each)
Distribution
Nationwide
Recall date
March 15, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls