The Recall Desk

FDA (Drugs) recall action 74822

Safecor Health, LLC recalled 6 products on 2017-06-21

The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2017-06-21
Critical
0
Units
3,600

Why these products were recalled

CGMP Deviations

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

1–6 of 6

  • ModerateFDA (Drugs)··2017-06-21

    Safecor Health Recalls Atorvastatin Calcium 40mg Tablets Due to CGMP Deviations

    Safecor Health is voluntarily recalling 119 bottles of Atorvastatin Calcium 40mg tablets in Massachusetts and New York due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Woburn, MA 01801, NDC 60505258009
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2017-06-21

    Safecor Health Recalls Calcium Carbonate and Vitamin D3 Tablets

    Safecor Health is recalling 25 bottles of Calcium Carbonate and Vitamin D3 tablets due to CGMP deviations. The product was distributed in Massachusetts and New York.

    Product
    Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904323392.
    Category
    Distribution
    2 states
  • SevereFDA (Drugs)··2017-06-21

    Safecor Health Recalls Doxycycline Tablets Due to Manufacturing Deviations

    Safecor Health LLC is recalling 856 bottles of Doxycycline 100mg tablets in Massachusetts and New York due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 0143314205
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2017-06-21

    Safecor Recalls Acyclovir 400mg Tablets Due to Manufacturing Deviations

    Safecor Health is recalling 601 bottles of Acyclovir 400mg tablets distributed in Massachusetts and New York due to CGMP deviations.

    Product
    Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health, LLC. Woburn, MA 01801, NDC 0093894305
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2017-06-21

    Safecor Health Recalls Metronidazole Tablets Due to CGMP Deviations

    Safecor Health LLC is voluntarily recalling 1,933 bottles of Metronidazole 500mg tablets due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 5011133402
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2017-06-21

    Safecor Health Recalls Acetaminophen Tablets Due to Manufacturing Deviations

    Safecor Health is recalling 66 bottles of Acetaminophen 325mg tablets due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot was distributed in Massachusetts and New York.

    Product
    Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904198280.
    Category
    Distribution
    2 states