The Recall Desk

FDA (Drugs) recall action 71946

Wockhardt Usa Inc. recalled 2 products on 2015-08-26

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
2015-08-26
Critical
0
Units
5,082

Why these products were recalled

CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

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

  • ModerateFDA (Drugs)··2015-08-26

    Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigations

    Wockhardt USA LLC is recalling 3,378 bottles of Lisinopril 20 mg tablets because an FDA inspection found inadequate investigations of past market complaints.

    Product
    Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 94106 5, NDC 64679-941-06.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2015-08-26

    Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigations

    Wockhardt USA is recalling 1,704 bottles of Lisinopril 5 mg tablets because an FDA inspection found inadequate investigations of past market complaints.

    Product
    Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.
    Category
    Distribution
    0 states