The Recall Desk

FDA (Drugs) recall action 86498

Direct Rx recalled 2 products on 2020-10-14

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-10-14
Critical
0
Units
26

Why these products were recalled

CGMP Deviations: Presence of NDMA impurity detected in product.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • SevereFDA (Drugs)··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.

    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
    Category
    Distribution
    2 states
  • SevereFDA (Drugs)··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.

    Product
    Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30
    Category
    Distribution
    2 states