The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1867-2019·Announced 2019-09-25

Aurolife Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures

Aurolife Pharma is recalling 71,748 bottles of Member's Mark fexofenadine hydrochloride tablets because they failed impurity and degradation specifications.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury or property damage reports, or structural defects, are Severe. While no specific injuries are reported in the text, the failure of impurity specifications in a pharmaceutical product is a significant quality defect that warrants a Severe rating under the Class II criteria provided.

Plain-English summary

Aurolife Pharma, LLC is recalling 71,748 bottles of Member's Mark fexofenadine hydrochloride tablets USP, 180 mg, 150-count. The product is distributed by Sam's West, Inc., in Bentonville, Arkansas, and was distributed nationwide in the USA.

The recall was initiated because the product failed impurities and degradation specifications. The affected lots include 067180009A, 067180013A, 067180014A, 067180015A, 067180018A, 067180020A, 067180021A1, 067180022A1, 06718028A1, 06718028B1, and 06719001A3, with expiration dates ranging from 03/21 to 01/22.

Consumers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled description, consumers should stop using it and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bentonville, AR 22716, NDC 68196-976-91, UPC 0 78742 23550 9.
Manufacturer
Aurolife Pharma, LLC
Category
Drug — Prescription/OTC Medication
Hazard
Affected units
71,748

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 (18)

  • Lot #'s: 067180009A
  • Exp 03/21
  • 067180013A
  • 067180014A
  • 067180015A
  • Exp 04/21
  • 067180018A
  • Exp 05/21
  • 067180020A
  • Exp 06/21
  • 067180021A1
  • 067180022A1
  • Exp 07/21
  • 06718028A1
  • 06718028B1
  • Exp 09/21
  • 06719001A3
  • Exp 01/22

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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