Remel Mueller-Hinton Broth Recalled for Incorrect Cation Labeling
Remel Inc is recalling 7 units of Mueller-Hinton Broth IVD because the product label may contain incorrect cation information.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 hazard is a labeling error regarding cation information without reported injuries or illnesses, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Remel Inc is recalling 7 units of CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres. The recall was initiated because the product may have incorrect cation information detailed on the product label.
The affected product is identified by Lot 1865331 with an expiration date of 06/2021. Distribution was made to Alabama, Maryland, Maine, North Carolina, and Tennessee. There was no foreign, military, or government distribution.
Consumers and healthcare facilities should stop using the affected product and contact Remel Inc for further instructions.
The recalled product
- Product
- CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.
- Manufacturer
- Remel Inc
- Hazard
- Affected units
- 7
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 (2)
- Lot 1865331
- Exp. 06/2021
Distribution
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