The Recall Desk
SevereFDA (Drugs)·D-1866-2019·Announced 2019-09-25

Aurolife Pharma Recalls Allergy Relief Tablets Due to Impurity Failures

Aurolife Pharma is recalling 3,240 cartons of Allergy Relief (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 'Severe' severity score (4) according to the rubric, as it involves a potential for temporary or medically reversible adverse health consequences.

Plain-English summary

Aurolife Pharma, LLC is recalling 3,240 cartons of Allergy Relief (fexofenadine hydrochloride) tablets, 180 mg, 5-count carton. The product is distributed by Amerisource Bergen and sold under the Good Neighbor Pharmacy brand. The recall is limited to Lot # 067180024A1 with an expiration date of 07/21.

The recall was initiated because the product failed impurities and degradation specifications. This is an FDA Class II recall, which indicates a situation where 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.

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 further instructions.

The recalled product

Product
Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good Neighbor Pharmacy, Distributed By Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-387-23.
Manufacturer
Aurolife Pharma, LLC
Category
Drug — Prescription/OTC Medication
Hazard
Affected units
3,240

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 #: 067180024A1
  • 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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