Home / Recalls / Medisca, Inc. / D-1174-2017

D-1174-2017 Class II Terminated

Recalled by Medisca, Inc. — Plattsburgh, NY

Recall Details

Product Type
Drugs
Report Date
September 27, 2017
Initiation Date
September 14, 2017
Termination Date
December 4, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
34,600 g

Product Description

Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient, packaged in a) 100 g jar (NDC 38779-0989-05, b) 1 kg jar (NDC 38779-0989-09), and 25 kg drum (NDC 38779-0989-07), Rx only, Packed by Medisca Inc., Plattsburgh, NY 12901, CAS: 60-32-1. 38779-0989-05; jar, 300 ml, white HDPE 38779-0989-07; drum, 15 gallon, Fiber 38779-0989-09; 2.8L, white, HDPE

Reason for Recall

CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.

Distribution Pattern

Nationwide in the USA

Code Information

Lots# 143595/A,143595/B,143595/D, Exp 02/28/20

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-0570-2024 Class II — Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline p (June 26, 2024)
  • 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-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-0665-2017 Class II — ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 (April 3, 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-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)