The Recall Desk

FDA (Drugs) recall action 84196

Lupin Pharmaceuticals Inc. recalled 3 products on 2019-11-13

The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2019-11-13
Critical
0
Units
58,770

Why these products were recalled

Presence of Foreign substance: identified as a dead ant.

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.

1–3 of 3

  • LowFDA (Drugs)··2019-11-13

    Lupin Recalls Cephalexin Oral Suspension Due to Foreign Substance

    Lupin Pharmaceuticals is recalling Cephalexin for Oral Suspension bottles because a dead ant was identified as a foreign substance.

    Product
    Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02
    Category
    Distribution
    0 states