AMUSA Recalls 0.9% Sodium Chloride Injection Due to Process Control Issues
MRP, LLC dba AMUSA is recalling 0.9% Sodium Chloride Injection because procedures for product acceptance and control were not adequately established.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a procedural failure in process control, which fits the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
MRP, LLC dba AMUSA is recalling 0.9% Sodium Chloride Injection, USP, 10mL in 12mL, Single use, Rx only, Sterile Solution. The recall involves 551 cases of the product.
The recall was initiated because procedures for the acceptance and control of in-process product have not been adequately established. The affected lots include KH04143 (exp. 07/2016), KH04145 (exp. 08/2016), KH04153 (exp. 11/2016), and KH04155 (exp. 12/2016).
The product was distributed in the states of California, Pennsylvania, Virginia, Texas, Massachusetts, Maryland, West Virginia, Utah, Florida, and Tennessee. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates and stop using the product if it matches the recalled description.
The recalled product
- Product
- 0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
- Manufacturer
- MRP, LLC dba AMUSA
- Hazard
- Affected units
- 551
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 (8)
- KH04143
- exp. 07/2016
- KH04145
- exp. 08/2016
- KH04153
- exp. 11/2016
- KH04155
- exp. 12/2016
Distribution
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