Drug 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
D-1174-2017
Product summary
- Firm
- Medisca, Inc.
- Event
- Event 78123
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34,600 g
- Official record key
drug-enforcement:D-1174-2017
Official wording
Reason: CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
Code information: Lots# 143595/A,143595/B,143595/D, Exp 02/28/20
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations