The Recall Desk

FDA (Drugs) recall action 80838

Westlab Pharmacy, Inc. dba Westlab Pharmacy recalled 3 products on 2018-10-31

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
2018-10-31
Critical
0
Units
309

Why these products were recalled

Incorrect Product Formulation

Lack of Process Controls

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

  • ModerateFDA (Drugs)··2018-10-31

    Westlab Pharmacy Recalls Alprostadil Injectable Vials Due to Incorrect Formulation

    Westlab Pharmacy is recalling 80 vials of Alprostadil 500 mcg/mL Injectable due to an incorrect product formulation. The recall covers nationwide distribution.

    Product
    Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-10-31

    Westlab Pharmacy Recalls ADAA Cataract Drops Due to Process Control Issues

    Westlab Pharmacy is recalling 222 syringes of ADAA Cataract Drops nationwide due to a lack of process controls.

    Product
    ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1cc syringe, Westlab Pharmacy, Inc., Gainesville, FL 32607 --- NDC 10002-2579-05
    Category
    Distribution
    0 states