Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1), sunmark, Distributed by McKesson, One Post Street, San Francisco, CA 94104.
Reported: September 25, 2019 Initiated: August 23, 2019 #D-1868-2019
Product Description
Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1), sunmark, Distributed by McKesson, One Post Street, San Francisco, CA 94104.
Reason for Recall
Failed Impurities/Degradation Specifications
Details
- Recalling Firm
- Aurolife Pharma, LLC
- Units Affected
- a) 11,928 cartons; b) 288 cartons
- Distribution
- Nationwide in the USA
- Location
- Dayton, NJ
Frequently Asked Questions
What product was recalled? ▼
Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1), sunmark, Distributed by McKesson, One Post Street, San Francisco, CA 94104.. Recalled by Aurolife Pharma, LLC. Units affected: a) 11,928 cartons; b) 288 cartons.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 25, 2019. Severity: Moderate. Recall number: D-1868-2019.
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