Recalls / Class II

Class IID-1174-2017

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

Affected lot / code info

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

Why it was recalled

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

Recalling firm

Firm

Medisca, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

661 State Route 3 Unit C, N/A, Plattsburgh, New York 12901-6531

Distribution

Quantity

34,600 g

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2017-09-14

FDA classified

2017-09-20

Posted by FDA

2017-09-27

Terminated

2018-12-04

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1174-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.