D-1868-2019 Class II Terminated
FDA drug recall D-1868-2019 was initiated by Aurolife Pharma, LLC on Aug 23, 2019 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated Aug 16, 2022). Affected quantity: a) 11,928 cartons; b) 288 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 25, 2019
- Initiation Date
- Aug 23, 2019
- Termination Date
- Aug 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 11,928 cartons; b) 288 cartons
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
Distribution Pattern
Nationwide in the USA
Code Information
Lot #s: a) 067180016B, Exp 05/21 and b) 067180024F1, Exp 07/21
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1868-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026