Medisca Recalls Aminocaproic Acid API Due to CGMP Labeling Deviations
Medisca, Inc. is recalling Aminocaproic Acid API lots because the product was manufactured for industrial use but labeled for pharmacy compounding.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling/CGMP deviation rather than a confirmed contamination or injury, fitting the Moderate category for minor labeling errors or low-risk deviations.
Plain-English summary
Medisca, Inc. is recalling specific lots of Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient (API). The affected product is packaged in 100 g jars, 1 kg jars, and 25 kg drums and is labeled for prescription use only. The recall involves lots 143595/A, 143595/B, and 143595/D, which have an expiration date of 02/28/20.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the product was manufactured for industrial use but was incorrectly labeled and distributed for pharmacy compounding use. This mislabeling creates a risk that the API may not meet the quality standards required for pharmaceutical compounding.
The product was distributed nationwide in the USA. Pharmacies and compounding facilities should stop using the affected lots and contact Medisca, Inc. for instructions on return or disposal. Consumers should not use this product, as it is an active pharmaceutical ingredient intended for professional use, not direct consumer consumption.
The recalled product
- 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;
- Manufacturer
- Medisca, Inc.
- Affected units
- 34,600
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lots# 143595/A
- 143595/B
- 143595/D
- Exp 02/28/20
Distribution
Distributed nationwide across the United States.
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