The Recall Desk

FDA (Drugs) recall action 92058

Amerisource Health Services LLC recalled 3 products on 2023-05-31

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
2023-05-31
Critical
0
Units
298,545

Why these products were recalled

CGMP Deviations: recalling drug products following an FDA inspection.

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)··2023-05-31

    Nationwide Recall of Glimepiride Tablets for Manufacturing Practice Deviations

    Amerisource Health Services LLC recalls 63,335 bottles of Glimepiride Tablets nationwide due to manufacturing practice deviations identified during FDA inspection.

    Product
    Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2023-05-31

    Glimepiride 4 Milligram Tablets Nationwide Recalled for Manufacturing Practice Deviations

    Amerisource Health Services LLC is recalling 129,849 bottles of Glimepiride Tablets, USP 4 mg nationwide due to manufacturing practice deviations identified during an FDA inspection. No illnesses have been reported.

    Product
    Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-05-31

    Glimepiride Tablets recalled due to manufacturing practice deviations

    Amerisource Health Services is recalling 105,361 bottles of Glimepiride Tablets nationwide following FDA discovery of manufacturing practice deviations. No illnesses have been reported.

    Product
    Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories
    Category
    Distribution
    0 states
Amerisource Health Services LLC recalled 3 products on 2023-05-31 · The Recall Desk