The Recall Desk

FDA (Drugs) recall action 88629

Morton Grove Pharmaceuticals, Inc. recalled 3 products on 2021-09-29

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
2021-09-29
Critical
0
Units
170,052

Why these products were recalled

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

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

  • HighFDA (Drugs)··2021-09-29

    Promethazine With Codeine Oral Solution Recall Due to Microbial Contamination

    Morton Grove Pharmaceuticals is recalling Promethazine With Codeine Oral Solution (Lot #UV1198) nationwide due to potential microbial contamination in liquid sugar batches used during manufacturing.

    Product
    Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053.…
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2021-09-29

    Promethazine Syrup Plain Recall Due to Microbial Contamination

    Morton Grove Pharmaceuticals is recalling Promethazine Syrup Plain 6.25 mg/5 mL in 1-pint bottles due to potential microbial contamination in liquid sugar batches used during manufacturing.

    Product
    Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2021-09-29

    Valproic Acid Oral Solution recalled for microbial contamination

    Morton Grove Pharmaceuticals is recalling Valproic Acid Oral Solution (250 mg/5 mL) due to potential microbial contamination in liquid sugar batches used during manufacturing.

    Product
    Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16
    Category
    Distribution
    0 states