The Recall Desk

FDA (Drugs) recall action 66988

GlaxoSmithKline, LLC. recalled 2 products on 2014-01-01

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
2014-01-01
Critical
0
Units
20,212

Why these products were recalled

Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.

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.

1–2 of 2

  • SevereFDA (Drugs)··2014-01-01

    GlaxoSmithKline Recalls Sumatriptan Injection Cartridges Due to Sterility Concerns

    GlaxoSmithKline is recalling 9,743 cartridges of Sumatriptan Succinate Injection because some may have needles protruding through the shield, compromising sterility.

    Product
    Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumatriptan Autoinjector Pen, Manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 for Sandoz Inc., Princeton, NJ 08540, Made in Sing
    Category
    Distribution
    0 states