CLASS II Drug recall · Reported 27 Sep 2017 · FDA Enforcement Report
Aminocaproic Acid, USP (6-Aminohexanoic Acid) active recalled by Medisca
Medisca is recalling Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient, distributed nationwide in the US. The recall was initiated on 14 Sep 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1174-2017
- FDA event ID
- 78123
- Recalling firm
- Medisca, Plattsburgh, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Sep 2017
- FDA classified
- 20 Sep 2017
- Reported
- 27 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 14 Sep 2017 | Recall initiated by company | |
| 20 Sep 2017 | Classified by FDA | +6 days |
| 27 Sep 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
Which lots are affected?
Lots# 143595/A,143595/B,143595/D, Exp 02/28/20
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medisca
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bimatoprost powder, Bulk Ingredient, a) recalled by Medisca | Medisca | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Budesonide, USP (Micronized), 500 mg recalled by Medisca | Medisca | Particulate Matter | Nationwide |
| Drug | CLASS II | Estriol, USP (Micronized), containers recalled by Medisca | Medisca | Potency & Assay | Nationwide |
| Drug | CLASS II | Estrone, USP Bulk, in a) 100 mgs recalled by Medisca | Medisca | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Estradiol, USP Bulk (Hemihydrate), in a) recalled by Medisca | Medisca | Manufacturing (CGMP) Deviations | Nationwide |
Other Aminocaproic Acid recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Aminaocaproic Acid Injection, USP, 250 mg/mL recalled by American RegentAminocaproic Acid | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS III | Aminocaproic Acid Oral Solution/mL recalled by VistaPharm | VistaPharm | Packaging Defects | Nationwide |
| Drug | CLASS II | Aminocaproic Acid 0.5mg/ml Injection,compounded by Olympia recalled | Lowlite Investments | Sterility | Nationwide |
| Drug | CLASS II | Aminocaproic Acid 250 mg/ml Injection recalled by Lowlite Investments | Lowlite Investments | Sterility | Nationwide |