The Recall Desk

FDA (Drugs) recall action 66607

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalled 2 products on 2015-01-28

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
2015-01-28
Critical
0
Units
15,643

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

1–2 of 2

  • ModerateFDA (Drugs)··2015-01-28

    Mylan Lamotrigine Tablets Recalled for CGMP Deviations

    Mylan Institutional is recalling 3,993 cartons of Lamotrigine 200 mg tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-866-20
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-01-28

    Mylan Recalls Ciprofloxacin Tablets Due to Manufacturing Deviations

    Mylan Institutional, Inc. is recalling Ciprofloxacin Tablets 500 mg because they were produced with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-182-20.
    Category
    Distribution
    1 state