EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22, UPC 0 41163 48067 4; b) 70 tablets per bottle, NDC 41163-571-01, UPC 0 41163 49847 1; Made in the Czech Republic, Distributed by: UNFI Providence, RI 02908.
Reported: January 12, 2022 Initiated: July 27, 2021 #D-0328-2022
Product Description
EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22, UPC 0 41163 48067 4; b) 70 tablets per bottle, NDC 41163-571-01, UPC 0 41163 49847 1; Made in the Czech Republic, Distributed by: UNFI Providence, RI 02908.
Reason for Recall
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Details
- Recalling Firm
- Perrigo Company PLC
- Units Affected
- 55,032 units
- Distribution
- Nationwide in the USA
- Location
- Allegan, MI
Frequently Asked Questions
What product was recalled? ▼
EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22, UPC 0 41163 48067 4; b) 70 tablets per bottle, NDC 41163-571-01, UPC 0 41163 49847 1; Made in the Czech Republic, Distributed by: UNFI Providence, RI 02908.. Recalled by Perrigo Company PLC. Units affected: 55,032 units.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 12, 2022. Severity: Moderate. Recall number: D-0328-2022.
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