The Recall Desk

FDA (Drugs) recall action 92054

Direct Rx recalled 3 products on 2023-04-12

The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2023-04-12
Critical
0
Units
378

Why these products were recalled

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

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.

1–3 of 3

  • ModerateFDA (Drugs)··2023-04-12

    Alprazolam 1 mg tablets recalled due to manufacturing contamination concerns

    Direct Rx is recalling Alprazolam 1 mg tablets nationwide due to potential cross contamination at the manufacturer. No illnesses or injuries have been reported.

    Product
    Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-04-12

    Alprazolam 0.5 mg tablets recalled due to manufacturing contamination

    Direct Rx is recalling Alprazolam 0.5 mg tablets (Lot 11AP2219, expires 4/30/23) nationwide due to potential cross-contamination concerns at the manufacturer. No illnesses have been reported.

    Product
    Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2023-04-12

    Alprazolam 2 mg tablets recalled due to potential manufacturing cross-contamination

    Direct Rx is recalling Alprazolam C-IV 2 mg tablets (NDC 72189-121-60) due to potential cross-contamination at the manufacturer. Nine bottles distributed nationwide; affected lots include 03FE2319 and 13MY2217.

    Product
    Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.
    Category
    Distribution
    0 states