The Recall Desk

FDA (Drugs) recall action 66403

Mylan Pharmaceuticals Inc. recalled 12 products on 2013-11-13

The FDA (Drugs) publishes a recall like this one as 12 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 12 pages.

Products
12
Announced
2013-11-13
Critical
0
Units
1,450,336

Why these products were recalled

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

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

1–12 of 12

  • SevereFDA (Drugs)··2013-11-13

    Mylan Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate Tablets, 5 mg, because they were produced with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC 0378-5209-77) and b) 500-count bottles (NDC 0378-5209-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2013-11-13

    Mylan Recalls Amlodipine Besylate Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate Tablets, 2.5 mg, because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC 0378-5208-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles (NDC 0378-6897-01) and b) 500-count bottles (NDC 0378-6897-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2013-11-13

    Mylan Recalls Lamotrigine Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling 28,140 bottles of 200 mg Lamotrigine tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling specific lots of Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6899-01
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2013-11-13

    Mylan Recalls Ciprofloxacin Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Ciprofloxacin 500 mg tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-7098-01
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2013-11-13

    Mylan Recalls Amlodipine Besylate Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate Tablets 10 mg because they were produced with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC 0378-5210-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b) 500-count bottles (NDC 0378-6896-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to CGMP Deviations

    Mylan Pharmaceuticals is recalling specific lots of Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-6895-01
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC# 0378-6898-05) labeled in part ***Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.***
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling specific lots of Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6900-01
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2013-11-13

    Mylan Recalls Ciprofloxacin Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling 521 bottles of Ciprofloxacin 250 mg tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7097-01
    Category
    Distribution
    1 state