Drug recall: Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick…
Class II FDA enforcement event 83581. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Failed Impurities/Degradation Specifications
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Aurolife Pharma, LLC started this drug recall on 23 Aug 2019. The firm address in the FDA record is in Dayton, NJ. FDA put the recall in Class II. FDA event 83581 has 11 product records. The first FDA enforcement report date is 25 Sep 2019. The record gives the status Terminated, with the termination date 16 Aug 2022.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide in the USA
Recalling firm
Aurolife Pharma, LLC, Dayton, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
11 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1864-2019 | Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21 | 8,240 bottles | Class II | Terminated | 25 Sep 2019 |
| D-1865-2019 | Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53); b) 30-count cartons (NDC 60000-409-30); c) 45-count bonus cartons (NDC 60000-409-48); d) 45-count cartons (NDC 60000-409-45); CAREone, Distributed by: Foodhold U.S.A., LLC, Landover, MD 20785. | a) 9662 cartons; b) 7382 cartons; c) 5184 cartons; d) 9842 cartons | Class II | Terminated | 25 Sep 2019 |
| D-1866-2019 | Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good Neighbor Pharmacy, Distributed By Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-387-23. | 3240 cartons | Class II | Terminated | 25 Sep 2019 |
| D-1867-2019 | fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bentonville, AR 22716, NDC 68196-976-91, UPC 0 78742 23550 9. | 71,748 bottles | Class II | Terminated | 25 Sep 2019 |
| D-1868-2019 | 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. | a) 11,928 cartons; b) 288 cartons | Class II | Terminated | 25 Sep 2019 |
| D-1869-2019 | Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-995-62. | 129,600 cartons | Class II | Terminated | 25 Sep 2019 |
| D-1870-2019 | Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1); and b) 30-count cartons (NDC 62011-0315-2) HealthMart PHARMACY, Distributed by McKesson, One Post Street, San Francisco, CA 94104. | a) 10,992 cartons; b) 24,792 cartons | Class II | Terminated | 25 Sep 2019 |
| D-1871-2019 | Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648; Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810. | 6104 bottles | Class II | Terminated | 25 Sep 2019 |
| D-1872-2019 | Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed by: Aurohealth LLC, 2572 Brunswick Pike, Lawrenceville, NJ 08648; NDC 58602-820-09. | 240 bottles | Class II | Terminated | 25 Sep 2019 |
| D-1873-2019 | Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0097-55. | 4920 cartons | Class II | Terminated | 25 Sep 2019 |
| D-1874-2019 | Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, NDC 53943-021-09. | 4536 cartons | Class II | Terminated | 25 Sep 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2019
- 362
- Share of these events in Class II
- 68%
- Product records in this event
- 11Median of the firm: 1
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 18 May 2023 | Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, | Drug | Class III | 1 |
| 16 Dec 2022 | Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08 | Drug | Class II | 1 |
| 17 Mar 2022 | Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton- | Drug | Class II | 1 |
Official channels
- FDA enforcement report D-1864-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 83581. https://recallregister.com/fda/ii/83581/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide in the USA
- What quantity of product is in FDA event 83581?
- The event has 11 product records. The first record gives this quantity:
8,240 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2019 have the same class?
- 68% of the 362 drug events that started in 2019 are in Class II.