The product may contain N-Nitrosodimethylamine (NDMA ), a substance that could cause cancer, above levels established by the FDA.
The firm has not received any reports of adverse events.
The following products, used for treatment of gastric disorders, are being recalled:
| Product Description | GSMS NDC | GSMS Lot # | Expiration Date |
|---|---|---|---|
| RANITIDINE HCl 150MG CAPSULES 500 Ct Bottle | 51407-097-05 | GS023970 | 10/31/2020 |
| GS026108 | 10/31/2020 | ||
| GS026099 | 10/31/2020 | ||
| GS026838 | 10/31/2020 | ||
| GS025702 | 10/31/2020 | ||
| GS027272 | 10/31/2020 | ||
| GS027273 | 05/31/2021 | ||
| RANITIDINE HCl 300MG CAPSULES 100 Ct Bottle | 51407-098-01 | GS023971 | 10/31/2020 |
| GS025527 | 10/31/2020 | ||
| GS025526 | 10/31/2020 | ||
| GS026114 | 10/31/2020 | ||
| GS025813 | 10/31/2020 | ||
| GS026189 | 10/31/2020 | ||
| GS027555 | 07/31/2021 | ||
| GS026190 | 05/31/2021 | ||
| GS026220 | 05/31/2021 | ||
| GS026584 | 05/31/2021 | ||
| GS027139 | 05/31/2021 | ||
| GS027554 | 05/31/2021 |
The lots being recalled were primarily sold to AmerisourceBergen, McKesson, and Tricare Mail Order Pharmacies (TMOP).
What to do
Patients taking the recalled products should consult with their physician, pharmacist, or healthcare provider about an alternative treatment prior to discontinuing the use of the medication.
Once an alternative treatment has been prescribed, patients should contact the recall processor at (866) 382-8606 or by email at Novitiumpharma6639@stericycle.com to obtain instructions and kit for returning the remaining product.
Consumers with questions may contact GSMS at (800) 284-8633, ext. 215 Monday through Friday from 7:30 AM to 4:00 PM (PT) by fax at (805) 437-7588 or by email at recalls@gsms.us