Mucinex FastMax Caplets Cold Flu Recalled for Improper Storage Conditions
Family Dollar Stores is recalling Mucinex FastMax Caplets Cold Flu 4CT (SKU 903372) distributed nationwide from April to June 2022 due to improper storage temperature conditions.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a manufacturing practice deviation involving improper medication storage, which represents a risk-of-harm scenario. No illnesses or injuries have been reported.
Plain-English summary
Family Dollar Stores, LLC is recalling Mucinex FastMax Caplets Cold Flu 4CT (SKU 903372) distributed to select Family Dollar locations nationwide between April 30, 2022 and June 10, 2022. The product was held outside the appropriate storage temperature conditions, a deviation from FDA Current Good Manufacturing Practice (CGMP) standards.
No illnesses or injuries have been reported. Consumers who purchased this product should contact Family Dollar Stores for information about returning the medication for a refund or replacement.
The recalled product
- Product
- MUCINEX FASTMAX CAPLETS COLD FLU 4CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Manufacturer
- Family Dollar Stores, Llc.
- Category
- Drug — Cold and Cough Medication
- Hazard
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: 903372
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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