The Recall Desk
SevereFDA (Drugs)·D-1872-2019·Announced 2019-09-25

Aurolife Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures

Aurolife Pharma is recalling 240 bottles of 180 mg Fexofenadine Hydrochloride tablets because they failed impurity and degradation specifications.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, an FDA Class II recall involving a structural or quality defect in a drug product is assigned a severity score of 4 (Severe).

Plain-English summary

Aurolife Pharma, LLC is recalling 240 bottles of Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles. The product is distributed by Aurohealth LLC and carries the NDC 58602-820-09. The specific lot affected is 067180026A1, with an expiration date of 07/21.

The recall was initiated because the product failed impurities and degradation specifications. This indicates that the tablets did not meet the required quality standards regarding chemical purity and stability.

The affected product was distributed nationwide in the USA. Consumers who have this specific lot of medication should stop using it and contact their pharmacist or healthcare provider for guidance on returning the product or obtaining a replacement.

The recalled product

Product
Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed by: Aurohealth LLC, 2572 Brunswick Pike, Lawrenceville, NJ 08648; NDC 58602-820-09.
Manufacturer
Aurolife Pharma, LLC
Category
Drug — Antihistamine
Hazard
Affected units
240

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 #: 067180026A1
  • Exp 07/21

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Aurolife Pharma, LLC 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 11 products in this recall →

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