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FDAFDA · Food and drugs·Recall number D-1174-2017

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

Published September 27, 2017 · Recall initiated: September 14, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Medisca, Inc.
Distributor
Nationwide in the USA
Lot
Lots# 143595/A,143595/B,143595/D, Exp 02/28/20
Risk classification
Class II
Area (FDA)
drug
Country
United States

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