The Recall Desk

FDA (Drugs) recall action 85169

Lupin Pharmaceuticals Inc. recalled 2 products on 2020-03-18

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
2020-03-18
Critical
0
Units
11,609

Why these products were recalled

Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.

Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.

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)··2020-03-18

    Lupin Recalls Levonorgestrel and Ethinyl Estradiol Tablets for Content Uniformity

    Lupin Pharmaceuticals is recalling specific lots of oral contraceptive tablets due to failed content uniformity tests.

    Product
    Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-857-13); Rx Only, Distributed by: Lupin Pharmaceuticals, Inc.…
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2020-03-18

    Lupin Recalls Bekyree Tablets Due to Content Uniformity Failures

    Lupin Pharmaceuticals is recalling specific lots of Bekyree oral contraceptives because they failed content and blend uniformity tests.

    Product
    Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals…
    Category
    Distribution
    1 state