Novitium Pharma is recalling all quantities and lots of Ranitidine Hydrochloride capsules in the U.S.
The product is contaminated with N-Nitrosodimethylamine (NDMA), a probable human carcinogen, above levels established by the FDA.
The recalled product is used for treatment of duodenal ulcer, benign gastric ulcer, reflux esophagitis, post-operative peptic ulcer, Zollinger-Ellison Syndrome, and other conditions where reduction of gastric secretion and acid output is desirable.
The following products are being recalled:
Description | Strength | Type | Pack Size |
NDC |
|---|---|---|---|---|
| Ranitidine Capsules 150mg | 150 mg | Rx | 60 ct bottle | 70954-001-20 |
| Ranitidine Capsules 150mg | 150 mg | Rx | 500 ct bottle | 70954-001-40 |
| Ranitidine Capsules 300mg | 300 mg | Rx | 30 ct bottle | 70954-002-10 |
| Ranitidine Capsules 300mg | 300 mg | Rx | 100 ct bottle | 70954-002-40 |
What to do
Patients should continue taking their medication and speak to their physician or pharmacist about alternate healthcare treatment options. Customers desiring to return product should contact the pharmacy from which it was purchased.
Consumers with questions may contact the company at (609) 469-5920 or by email at info@novitiumpharma.com.
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