The Recall Desk
SevereFDA (Drugs)·D-1874-2019·Announced 2019-09-25

Aurolife Pharma Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures

Aurolife Pharma is recalling 4,536 cartons 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 recall is classified as FDA Class II, which corresponds to a severity score of 4 (Severe) according to the rubric, as it involves a product that may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Aurolife Pharma, LLC is recalling 4,536 cartons of Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count. The product is distributed by Discount Drug Mart in Medina, Ohio, and was available nationwide in the United States. The specific lot number is 067180024B1, with an expiration date of 07/21.

The recall was initiated because the product failed impurities and degradation specifications. This FDA Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers who have purchased this specific lot of medication should stop using it and contact their pharmacist or healthcare provider for guidance on disposal or replacement.

The recalled product

Product
Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, NDC 53943-021-09.
Manufacturer
Aurolife Pharma, LLC
Category
Drug — Antihistamine
Hazard
Affected units
4,536

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 #: 067180024B1
  • 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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