The products, used to treat heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages, are contaminated with N-Nitrosodimethylamine (NDMA), a probable human carcinogen, above levels established by the FDA.
The firm as not received any reports of adverse events to date.
The following products, which are packaged in bottles, are being recalled:
| Product Name | NDC | Batch Number | Exp. Date |
|---|---|---|---|
| Ranitidine Tablets 150mg | 55910-092-79 | NBSB19001DA3 | Feb-2021 |
| Ranitidine Capsules 150mg | 59651-144-60 | RA1518001-A | Jul-2020 |
| RA1518002-A | Jul-2020 | ||
| 59651-144-05 | RA1518002-B | Jul-2020 | |
| RA1518003-A | Jul-2020 | ||
| RA1518004-A | Aug-2020 | ||
| RA1518005-A | Aug-2020 | ||
| 59651-144-60 | RA1518005-B | Aug-2020 | |
| RA1518006-A | Aug-2020 | ||
| 59651-144-05 | RA1518007-A | Sep 2020 | |
| RA1518008-A | Sep 2020 | ||
| RA1518009-A | Sep 2020 | ||
| RA1518010-A | Oct 2020 | ||
| RA1518011-A | Nov 2020 | ||
| RA1518012-A | Nov 2020 | ||
| RA1518013-A | Nov 2020 | ||
| RA1518014-A | Nov 2020 | ||
| RA1518015-A | Nov 2020 | ||
| 59651-144-60 | RA1519003-A | May-2021 | |
| 59651-144-05 | RA1519003-B | May 2021 | |
| RA1519004-A | May 2021 | ||
| Ranitidine Capsules 300mg | 59651-145-30 | RA3018001-A | Jul-2020 |
| RA3018002-A | Jul-2020 | ||
| RA3018003-A | Jul-2020 | ||
| RA3018004-A | Aug-2020 | ||
| RA3018005-A | Aug-2020 | ||
| RA3018006-A | Aug-2020 | ||
| RA3018007-A | Sep-2020 | ||
| RA3018008-A | Sep-2020 | ||
| RA3018009-A | Sep-2020 | ||
| RA3018010-A | Oct-2020 | ||
| RA3019001-A | Jan 2021 | ||
| RA3019002-A | Jan 2021 | ||
| RA3019003-A | May-2021 | ||
| Ranitidine Syrup (Ranitidine Oral Solution, USP) 15 mg/mL (75 mg/5 mL) | 65862-431-74 | UI1519001-A | May-2021 |
| UI1519002-A | May-2021 | ||
| UI1519003-A | May-2021 | ||
| UI1519004-A | May-2021 |
The recalled products can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.
They were distributed nationwide to Aurobindo Pharma USA, Inc. and AuroHealth wholesale and distributor customers from September 28, 2018, through September 19, 2019.
What to do
Patients should continue taking their medication and contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.
Consumers with questions regarding the return of this product may contact Qualanex at (888) 504-2014 from 7:00 am to 4:00 pm (CST) Monday – Friday or by email at recall@qualanex.com.