The Recall Desk
ModerateFDA (Drugs)·D-0328-2022·Announced 2022-01-12

EQUALINE Fexofenadine Hydrochloride Tablets Recalled for Failed Impurity Testing

Perrigo Company is recalling EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, due to impurity A exceeding specification limits during stability testing. The recalled products were distributed nationwide.

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: This is an FDA Class II recall involving out-of-specification impurities detected during stability testing. The source text does not report any illnesses, injuries, or adverse events. The hazard is quality-related with no evidence of patient harm, consistent with a Moderate severity classification.

Plain-English summary

Perrigo Company PLC is recalling EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24-hour formulation. The recall affects two package configurations: 15-count bottles (NDC 41163-571-22, UPC 0 41163 48067 4, Lot # 0HE2530 Exp 12/31/2021 and 0KE2980 Exp 02/28/2022) and 70-tablet bottles (NDC 41163-571-01, UPC 0 41163 49847 1, Lot # 0FR0461 Exp 2/28/2022). The product was manufactured in the Czech Republic and distributed nationwide by UNFI, Providence, RI.

The recall was initiated because stability testing revealed that impurity A in the affected lots exceeded specification limits. This out-of-specification result indicates that the product does not meet the required quality standards for pharmaceutical products.

A total of 55,032 units are subject to this recall. Consumers who have purchased affected packages should stop using the product and consult their healthcare provider or pharmacist for guidance on alternative treatments.

The recalled product

Product
EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22, UPC 0 41163 48067 4; b) 70 tablets per bottle, NDC 41163-571-01, UPC 0 41163 49847 1; Made in the Czech Republic, Distributed by: UNFI Providence, RI 02908.
Manufacturer
Perrigo Company PLC
Category
Drug — Antihistamine / Allergy Medication
Hazard
  • impurity-degradation
  • out-of-specification

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 # a)0HE2530 Exp 12/31/2021
  • 0KE2980 EXP 02/28/2022 b)0FR0461 Exp 2/28/2022

Distribution

Distributed nationwide across the United States.

Related recalls

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