The Recall Desk
ModerateFDA (Drugs)·D-0348-2022·Announced 2022-01-12

Rite Aid Allergy Relief Fexofenadine tablets recalled for impurity

Perrigo Company PLC is recalling Rite Aid Allergy Relief Fexofenadine Hydrochloride 180mg tablets nationwide due to failed impurity specifications. An out-of-specification result for impurity A was found during stability testing.

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 a failed impurity specification with no reported illnesses or injuries. The hazard is a potential quality defect discovered through stability testing, which constitutes a moderate precautionary recall under the rubric criteria.

Plain-English summary

Perrigo Company PLC is recalling Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg. The recall affects 44,688 containers distributed nationwide in the USA.

The recall was initiated because an out-of-specification result was obtained for impurity A during stability testing, indicating the product failed impurity and degradation specifications.

Two package sizes are affected: 30-count bottles (NDC 11822-0571-2) and 150-count bottles (NDC 11822-0571-5). Affected lot numbers and expiration dates are: Lot 1BR0462 (Exp 10/31/2022), Lot 0GR0528 (Exp 3/31/2022), Lot 0KR0473 (Exp 4/30/2022), and Lot 0LR0369 (Exp 6/30/2022). The product was manufactured in the Czech Republic and distributed by Rite Aid.

Consumers should discontinue use of the affected lots and consult with their healthcare provider. The product was distributed nationwide.

The recalled product

Product
Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 30 count bottle, NDC 11822-0571-2 UPC 0 11822 99908 3; b) 150 count bottle, NDC 11822-0571-5 UPC 0 11822 85411 5; Made in the Czech Republic, Distributed by Rite Aid 30 Hunter
Manufacturer
Perrigo Company PLC
Category
Drug — Antihistamine / Impurity
Hazard
  • impurity-specification-failure
  • degradation-failure

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 (7)

  • Lot # a) 1BR0462
  • Exp 10/31/2022 b) 0GR0528
  • Exp 3/31/2022
  • 0KR0473
  • Exp 4/30/2022
  • 0LR0369
  • Exp 6/30/2022

Distribution

Distributed nationwide across the United States.

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