The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0016-2021·Announced 2020-10-14

Direct Rx Recalls Ranitidine 150 mg Tablets Due to NDMA Impurity

Direct Rx is recalling specific lots of Ranitidine 150 mg tablets because an NDMA impurity was detected. The affected products were distributed in Florida and Georgia.

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 under the rubric for drug recalls involving significant health risks like NDMA impurities.

Plain-English summary

Direct Rx is recalling specific lots of Ranitidine 150 mg tablets, available in 60-tablet and 90-tablet bottles. The recall was initiated because the presence of the NDMA impurity was detected in the product, which constitutes a Current Good Manufacturing Practice (CGMP) deviation.

The affected products are prescription-only and were packaged and distributed by Direct Rx in Dawsonville, GA. The recall covers 54 bottles of the 60-tablet size (Lot 09AU1911, Exp. 02/28/2022) and 26 bottles of the 90-tablet size (Lot 09SE1904, Exp. 03/31/2022). These products were distributed in Florida and Georgia.

Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider for guidance on alternative treatments or returns.

The recalled product

Product
Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534
Manufacturer
Direct Rx
Category
Drug — Prescription Medication
Hazard

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 (2)

  • Lots: a) 09AU1911 Exp. 02/28/2022
  • b) 09SE1904 Exp. 03/31/2022

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 →

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