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:

FDA recall notice · announced September 27, 2017 · Medisca

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lots# 143595/A,143595/B,143595/D, Exp 02/28/20
Quantity: 34,600 g
Status: Terminated
Products in this recall event:
- 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 onl (D-1174-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.