The Recall Desk

FDA (Drugs) recall action 76750

Mylan Pharmaceuticals Inc. recalled 4 products on 2017-04-05

The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2017-04-05
Critical
0
Units
2,428,689

Why these products were recalled

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

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

1–4 of 4

  • HighFDA (Drugs)··2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Pharmaceuticals is recalling specific lots of Atorvastatin Calcium 40 mg tablets due to potential microbial contamination and elevated bioburden.

    Product
    Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Pharmaceuticals is recalling Atorvastatin Calcium Tablets 20 mg due to potential microbial contamination and elevated bioburden.

    Product
    Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Pharmaceuticals is recalling specific lots of Atorvastatin Calcium 10 mg tablets due to potential microbial contamination and elevated bioburden.

    Product
    Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Pharmaceuticals is recalling Atorvastatin Calcium Tablets, 80 mg, due to potential microbial contamination and elevated bioburden.

    Product
    Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Distribution
    1 state