Mucinex SE Max Strength recalled for improper storage conditions
Family Dollar Stores is recalling Mucinex SE Max Strength 7CT distributed from April through June 2022 due to CGMP deviations involving improper storage temperature.
The agency’s classification
FDA (Drugs): 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: FDA Class II recall with no reported illnesses or injuries. The hazard is a CGMP storage temperature deviation with no demonstrated harm, making this a precautionary recall fitting the Moderate severity level per the rubric.
Plain-English summary
Family Dollar Stores is recalling Mucinex SE Max Strength 7CT due to CGMP (Current Good Manufacturing Practice) deviations. The product was held outside appropriate storage temperature conditions, which does not meet FDA manufacturing standards.
The affected product was distributed to Family Dollar Stores nationwide between April 30, 2022 and June 10, 2022. The product SKU is 900844.
No illnesses or injuries have been reported in connection with this recall. Consumers who have purchased this product should discontinue use and properly dispose of it.
The recalled product
- Product
- MUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Manufacturer
- Family Dollar Stores, Llc.
- Category
- Drug
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 (1)
- SKU: 900844
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 recalled by Family Dollar Stores, Llc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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