Novitium Pharma Recalls Ranitidine Capsules Due to NDMA Impurity
Novitium Pharma LLC is recalling 19,560 bottles of Ranitidine Capsules 150 mg nationwide because the product contains 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 agency classification is FDA Class II, which corresponds to a 'Severe' severity score (4) according to the rubric, particularly given the presence of a known hazardous impurity (NDMA).
Plain-English summary
Novitium Pharma LLC is recalling 19,560 bottles of Ranitidine Capsules 150 mg (NDC 70954-001-20). The recall covers all lots within the expiration date and the product was distributed nationwide.
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.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatments. The recalled product is prescription-only.
The recalled product
- Product
- Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20
- Manufacturer
- Novitium Pharma LLC
- Category
- Drug — Prescription Medication
- Affected units
- 19,560
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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