Novitium Pharma Recalls Ranitidine Capsules Due to NDMA Impurity
Novitium Pharma LLC is recalling Ranitidine Capsules 300 mg because the product was found to contain the NDMA impurity.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the presence of a known hazardous impurity (NDMA) in a pharmaceutical product.
Plain-English summary
Novitium Pharma LLC is recalling Ranitidine Capsules 300 mg, 30 capsules per bottle (NDC 70954-002-10). The recall involves 12,312 bottles distributed nationwide. All lots within the expiration date are affected.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. NDMA is a substance that has been associated with potential health risks in pharmaceutical products.
Consumers who have purchased these capsules should stop using them and contact their healthcare provider or pharmacist for guidance on alternative treatments. The product is prescription-only, so patients should consult their prescriber regarding next steps.
The recalled product
- Product
- Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-10
- Manufacturer
- Novitium Pharma LLC
- Category
- Drug — Prescription Medication
- Affected units
- 12,312
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Novitium Pharma LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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