The Recall Desk

FDA (Drugs) recall action 67739

Blu Pharmaceuticals Inc recalled 2 products on 2014-05-14

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
2014-05-14
Critical
0
Units
115,500

Why these products were recalled

Defective container: Product distributed without inner seal on bottles.

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)··2014-05-14

    Blu Pharmaceuticals Recalls Metformin Tablets Due to Missing Inner Seals

    Blu Pharmaceuticals is recalling 14,000 Metformin Hydrochloride tablets because the bottles were distributed without inner seals. The affected product was distributed in New Jersey, Utah, Illinois, and Connecticut.

    Product
    Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134 NDC 24658-290-05
    Category
    Distribution
    4 states
  • ModerateFDA (Drugs)··2014-05-14

    Blu Pharmaceuticals Recalls Metformin Tablets Due to Missing Inner Seals

    Blu Pharmaceuticals is recalling Metformin Hydrochloride 1000 mg tablets because bottles were distributed without inner seals. The affected lot was distributed in New Jersey, Utah, Illinois, and Connecticut.

    Product
    Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134, NDC 24658-0292-05
    Category
    Distribution
    4 states