The Recall Desk
SevereFDA (Drugs)·D-0017-2021·Announced 2020-10-14

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.

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 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

Distributed in 2 states:

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.

See all 2 products in this recall →

Related recalls

Same manufacturer · Direct Rx

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Same hazard · ndma impurity

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