The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0825-2018·Announced 2018-05-30

Mylan Recalls Loxapine Capsules Due to Manufacturing Deviations

Mylan Pharmaceuticals is voluntarily recalling 11,650 bottles of Loxapine Capsules 50 mg due to Current Good Manufacturing Practice (CGMP) deviations.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a High severity score (3) as it involves a risk of temporary or medically reversible adverse health consequences, without reported fatalities or serious injuries that would elevate it to Critical or Severe.

Plain-English summary

Mylan Pharmaceuticals Inc. is voluntarily recalling 11,650 bottles of Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles (NDC 0378-7050-01). The recall was initiated on April 24, 2018, due to Current Good Manufacturing Practice (CGMP) deviations. The affected lots are 3079386, 3079387, 3079388 (Exp. 10/31/18) and 3083762, 3083763, 3083764, 3083765, 3083766, 3083767 (Exp. 3/31/19).

The product was distributed throughout the United States, including Puerto Rico. The FDA classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance. The recall was terminated on August 14, 2019.

The recalled product

Product
Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Antipsychotic
Hazard
Affected units
11,650

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 (10)

  • NDC 0378-7050-01 Lot Numbers: 3079386
  • Exp. 10/31/18 3079387
  • Exp. 10/31/18 3079388
  • Exp. 10/31/18 3083762
  • Exp. 3/31/19 3083763
  • Exp. 3/31/19 3083764
  • Exp. 3/31/19 3083765
  • Exp. 3/31/19 3083766
  • Exp. 3/31/19 3083767
  • Exp. 3/31/19

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Mylan Pharmaceuticals Inc. 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 →

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