The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0493-2017·Announced 2017-03-15

Mylan Recalls Mirtazapine Tablets Due to Foreign Glipizide Contamination

Mylan Institutional is recalling Mirtazapine 45 mg tablets because they may contain foreign Glipizide 10 mg tablets.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the risk of administering the wrong medication (Glipizide instead of Mirtazapine).

Plain-English summary

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Mirtazapine Tablets, USP, 45 mg. The recall involves 58 UD100 Unit Dose Blister Cards of 10 tablets each, identified by Batch #3083289 and an expiration date of 12/2018. The product is distributed nationwide.

The recall was initiated due to the presence of foreign tablets or capsules, specifically the possibility that Glipizide 10 mg tablets are commingled with the Mirtazapine tablets. This contamination poses a risk of patients receiving an incorrect medication.

Patients and healthcare providers should discontinue use of the affected Mirtazapine tablets and contact their healthcare provider for appropriate medical evaluation and alternative treatment options. The recalling firm is responsible for managing the recall and providing further instructions to affected parties.

The recalled product

Product
MIRTAZAPINE (MIRTAZAPINE)
Brand
MIRTAZAPINE
Manufacturer
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Category
Drug — Prescription Drug
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Batch #3083289
  • Exp. Date 12/2018

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · MIRTAZAPINE

Same manufacturer · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

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Same hazard · foreign object

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