The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0822-2018·Announced 2018-05-30

Mylan Recalls Loxapine Capsules Due to Cross-Contamination Risk

Mylan Institutional, Inc. is recalling Loxapine Capsules 25 mg due to cGMP violations that create a risk of cross-contamination.

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 for drug recalls involving potential health risks.

Plain-English summary

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules. The recall involves 1,065 blister cards of 100 capsules each, identified by Lot # 3090454 with an expiration date of 03/2019. The product was distributed nationwide in the U.S.

The recall was initiated following a recent FDA inspection of the manufacturing site, which revealed multiple current Good Manufacturing Practice (cGMP) violations. These violations place the Loxapine product at risk for cross-contamination.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on replacement or disposal.

The recalled product

Product
Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20
Manufacturer
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Category
Drug — Antipsychotic
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)

  • Lot #: 3090454
  • Exp. 03/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

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

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