Aminocaproic Acid — Class II drug recall D-1174-2017
Terminated recall by Medisca, Inc., reported 2017-09-27, distributed nationwide. CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compoun
| Recall number | D-1174-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medisca, Inc., Plattsburgh, NY, United States |
| Recall initiated | 2017-09-14 |
| Classified | 2017-09-20 |
| Reported by FDA | 2017-09-27 |
| Terminated | 2018-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 34,600 g |
| Reason classes | labeling, cgmp |
| NDC | 38779-0989-05, 38779-0989-07, 38779-0989-09 |
| Lot numbers | 143595/A, 143595/B, 143595/D |
| Expiration dates | 2020-02-28 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1174-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.