Direct Rx Recalls Ranitidine 300 mg Tablets Due to NDMA Impurity
Direct Rx is recalling 26 bottles of Ranitidine 300 mg tablets because the product was found to contain the NDMA impurity.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 severity score according to the rubric.
Plain-English summary
Direct Rx is recalling 26 bottles of Ranitidine 300 mg, 30 Tabs bottles (NDC 61919-455-30). 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 lot number is 29JA1915, with an expiration date of 09/30/2021. The product was distributed in Florida and Georgia.
Consumers who have this specific lot of Ranitidine should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30
- Manufacturer
- Direct Rx
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 26
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)
- Lot: 29JA1915 Exp. 09/30/2021
Distribution
Part of a larger recall action
This product is one of 2 recalled by Direct Rx 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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