The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0824-2018·Announced 2018-05-30

Mylan Recalls Loxapine Capsules Due to Manufacturing Deviations

Mylan Pharmaceuticals is recalling 8,679 bottles of Loxapine Capsules 25 mg due to CGMP deviations. The product was distributed throughout the United States and Puerto Rico.

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 indicates a situation that may cause temporary or medically reversible adverse health consequences. The hazard involves CGMP deviations, which is a risk-of-harm scenario where specific injury reports are not detailed in the source text, fitting the High severity criteria for risk-of-harm products.

Plain-English summary

Mylan Pharmaceuticals Inc. is voluntarily recalling 8,679 bottles of Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles (NDC 0378-7025-01). The recall was initiated on April 24, 2018, and was classified as Class II by the FDA. The reason for the recall is cited as Current Good Manufacturing Practice (CGMP) deviations.

The affected product includes six specific lot numbers: 3083756, 3083757, 3083758, 3083759, 3083760, and 3083761, all with an expiration date of March 31, 2019. The product was distributed throughout the United States, including Puerto Rico. Mylan Pharmaceuticals Inc. is located in Morgantown, West Virginia.

Consumers and healthcare providers should check their inventory for these specific lot numbers and NDC codes. If found, the product should be returned to the distributor or the recalling firm. The recall status is currently terminated as of August 14, 2019.

The recalled product

Product
Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Antipsychotic
Hazard
Affected units
8,679

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 (7)

  • NDC # 0378-7025-01 Lot Numbers: 3083756
  • Exp. 3/31/19 3083757
  • Exp. 3/31/19 3083758
  • Exp. 3/31/19 3083759
  • Exp. 3/31/19 3083760
  • Exp. 3/31/19 3083761
  • 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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