The Recall Desk
ModerateFDA (Drugs)·D-0350-2022·Announced 2022-01-12

TopCare Allergy Relief Fexofenadine tablets recalled for impurity specifications

Perrigo Company PLC is recalling TopCare Allergy Relief Fexofenadine Hydrochloride 180mg tablets in multiple pack sizes due to failed impurity specifications during stability testing. The affected lots were distributed nationwide.

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 failed impurity specifications during stability testing. No illness, injury, or adverse event is reported in the source text. The hazard is a quality specification failure detected proactively during testing, making this a moderate precautionary recall.

Plain-English summary

Perrigo Company PLC is recalling TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24-hour formula, 180mg, in four pack sizes: 5-count, 15-count, 45-count, and 90-count bottles. The recall was initiated because an out-of-specification result for impurity A was obtained during stability testing, indicating the product failed impurity and degradation specifications.

The affected products were distributed nationwide in the United States. A total of 13,656 containers are involved in the recall. The recalled lots and their expiration dates are: Lot 0KE2429 (Exp. 02/28/2022), Lot 0HE2530 (Exp. 12/31/2021), Lot 0FR0460 (Exp. 02/28/2022), Lot 0GR0531 (Exp. 03/31/2022), and Lot 0KR0465 (Exp. 04/30/2022). The product was manufactured in the Czech Republic and distributed by Topco Associates LLC, Elk Grove Village, IL.

Consumers who have purchased this product should stop using it and consult their healthcare provider if they have questions about their use of the recalled medication. The specific NDC and UPC codes affected are provided for identification and removal from shelves.

The recalled product

Product
TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, NDC 36800-319-13 UPC 0 36800 33277-5 b) 15 count bottle, NDC 36800-319-22 UPC 0 36800 33278 2; c) 45 count bottle, NDC 36800-319-95 UPC 0 36800 33280-5; d) 90
Manufacturer
Perrigo Company PLC
Category
Drug — Antihistamine tablet
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 (9)

  • Lot # a) 0KE2429
  • Exp 02/28/2022
  • b) 0HE2530
  • Exp 12/31/2021
  • c)0FR0460
  • d)0GR0531
  • Exp 03/31/2022
  • 0KR0465
  • Exp 04/302022

Distribution

Distributed nationwide across the United States.

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