Home / Recalls / Medisca Inc. / D-0570-2024

D-0570-2024 Class II

Recalled by Medisca Inc. — Irving, TX

Recall Details

Product Type
Drugs
Report Date
July 10, 2024
Initiation Date
June 26, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
113 bottles

Product Description

Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.

Reason for Recall

CGMP Deviations and Presence of Particulate Matter: Glass

Distribution Pattern

Nationwide in the USA and Canada

Code Information

Lot #s: 202323/G, 202323/H, Exp. 07/31/2026

Other recalls by Medisca Inc.

  • D-0386-2025 Class II — Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779 (March 31, 2025)
  • D-0622-2020 Class II — Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packe (November 25, 2019)
  • D-1174-2017 Class II — Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient, (September 14, 2017)
  • D-0666-2017 Class II — ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (April 3, 2017)
  • D-0665-2017 Class II — ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 (April 3, 2017)
  • D-0664-2017 Class II — ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891- (April 3, 2017)
  • D-0663-2017 Class II — ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams ( (April 3, 2017)
  • D-0674-2016 Class I — CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or (February 14, 2014)
  • D-1263-2014 Class I — Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use (October 21, 2013)