Novitium Pharma Recalls Ranitidine Capsules Due to NDMA Impurity
Novitium Pharma LLC is recalling Ranitidine Capsules 300 mg because of the presence of the NDMA impurity. The recall covers 6,660 bottles distributed nationwide.
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 and involves the presence of NDMA, a known carcinogenic impurity, which aligns with the rubric criteria for Severe severity.
Plain-English summary
Novitium Pharma LLC is recalling 6,660 bottles of Ranitidine Capsules 300 mg (NDC 70954-002-40). The product is a prescription-only medication manufactured by Novitium Pharma LLC in East Windsor, New Jersey. The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product.
The affected product was distributed nationwide. The recall includes all lots within their expiration dates. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments or returns.
The recalled product
- Product
- Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-40
- Manufacturer
- Novitium Pharma LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 6,660
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.
See all 4 products in this recall →Related recalls
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