The Recall Desk
ModerateFDA (Drugs)·D-0823-2018·Announced 2018-05-30

Mylan Recalls Loxapine Capsules Due to Cross-Contamination Risk

Mylan Institutional, Inc. is recalling Loxapine Capsules 50 mg due to cGMP violations that create a risk of cross-contamination.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a theoretical risk of cross-contamination due to cGMP violations without reporting specific illnesses or injuries, aligning with the criteria for a moderate severity score.

Plain-English summary

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules. The affected product is identified by Lot # 3092310 with an expiration date of 03/2019. The recall involves 1,152 blister cards of 100 capsules each, which were 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.

Healthcare providers and patients should discontinue use of the affected Loxapine Capsules and contact their healthcare provider for alternative treatment options. The recalling firm is responsible for managing the recall and ensuring the product is removed from distribution.

The recalled product

Product
Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-903-20.
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 #: 3092310
  • 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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Same hazard · cross contamination

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