The Recall Desk

FDA (Drugs) recall action 89749

Direct Rx recalled 2 products on 2022-03-16

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
2022-03-16
Critical
0
Units
24

Why these products were recalled

CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)

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

  • ModerateFDA (Drugs)··2022-03-16

    Alprazolam 1 mg recalled for potential cross-contamination at manufacturer

    Direct Rx is recalling Alprazolam C-IV 1 mg 60-count bottles due to potential cross-contamination at the contract manufacturer, Ultra Tab Laboratories Inc. The recall affects 16 bottles distributed to Florida, Georgia, and Louisiana.

    Product
    Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2022-03-16

    Alprazolam 2 mg tablets recalled due to potential cross-contamination

    Direct Rx is recalling Alprazolam C-IV 2 mg tablets (Lot #07NO1901, expiration 5/31/22) distributed in Florida, Georgia, and Louisiana due to potential cross-contamination identified at the contract manufacturer Ultra Tab Laboratories Inc.

    Product
    Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0058-60
    Category
    Distribution
    3 states