The products, used for the treatment of conditions including duodenal ulcer, benign gastric ulcer, reflux esophagitis, are contaminated with N-Nitrosodimethylamine (NDMA) above levels established by the FDA.
NDMA is classified as a probable substance that could cause cancer.
Appco has not received any reports of adverse events to date.
The following products, packaged in bottles, are being recalled:
| Description | Strength | NDC | Batch # | Counts | Expiration date |
|---|---|---|---|---|---|
| Ranitidine Capsules 300 mg | 300 mg | 62559-691-30 | 1905227UE | 30’s | Apr-21 |
| 300 mg | 62559-691-30 | 1905228UE | 30’s | Apr-21 | |
| Ranitidine Capsules 150 mg | 150 mg | 62559-690-60 | 1905225VN | 60’s | Apr-21 |
| 150 mg | 62559-690-05 | 1905226VD | 500’s | Apr-21 | |
| 150 mg | 62559-690-60 | 1906295UN | 60’s | May-21 | |
| 150 mg | 62559-690-60 | 1906296UN | 60’s | May-21 | |
| 150 mg | 62559-690-60 | 1906297UN | 60’s | May-21 | |
| 150 mg | 62559-690-05 | 1906298UD | 500’s | May-21 |
The recalled products were sold nationwide.
What to do
Patients who have the recalled products should stop using and return them to place of purchase and speak to their physician or pharmacist about alternate options.
Consumers with questions may contact Appco at (732) 253-7735 from 8 am – 6 pm (EST), Monday – Friday, or by e-mail at pv@appcopharma.com or ANI Pharmaceuticals (800) 308-6755 or by email at PVSupport@safetycall.com.