Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0413-1, UPC 0 52569 14278 3
Reported: January 12, 2022 Initiated: July 27, 2021 #D-0337-2022
Product Description
Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0413-1, UPC 0 52569 14278 3
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
- 12,384 containers
- Distribution
- Nationwide in the USA
- Location
- Allegan, MI
Frequently Asked Questions
What product was recalled? ▼
Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0413-1, UPC 0 52569 14278 3. Recalled by Perrigo Company PLC. Units affected: 12,384 containers.
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-0337-2022.
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