Aurolife Pharma, LLC

FDA Regulatory Profile

Summary

Total Recalls
14
510(k) Clearances
0
Inspections
11
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0877-2023Class IIIGlycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA,May 18, 2023
D-0087-2023Class IIGlycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc.,December 16, 2022
D-0736-2022Class IIGlycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, March 17, 2022
D-1865-2019Class IIAllergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NAugust 23, 2019
D-1874-2019Class IIAllergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD August 23, 2019
D-1867-2019Class IIfexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: SamAugust 23, 2019
D-1871-2019Class IIFexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 BruAugust 23, 2019
D-1869-2019Class IIAllergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: WalAugust 23, 2019
D-1872-2019Class IIAllergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed by: AurohealAugust 23, 2019
D-1870-2019Class IIFexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1); August 23, 2019
D-1864-2019Class IIFexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., August 23, 2019
D-1868-2019Class IIFexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) anAugust 23, 2019
D-1873-2019Class IIWal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed By: Walgreen August 23, 2019
D-1866-2019Class IIAllergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good Neighbor PharmacyAugust 23, 2019