Mylicon Infant Gas Drops Recalled Due to Temperature Storage Deviation
Family Dollar Stores is recalling Mylicon Infant Gas Drops 0.5 oz distributed nationwide from April 30 through June 10, 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: This is an FDA Class II recall for improper storage of an infant medication. Storage-temperature deviations can affect medication stability and safety, particularly for vulnerable infant consumers, warranting High severity classification.
Plain-English summary
Family Dollar Stores, Llc. is recalling Mylicon Infant Gas Drops 0.5 oz due to Current Good Manufacturing Practice (CGMP) deviations. The product was held outside of appropriate storage temperature conditions.
The affected product was distributed nationwide to Family Dollar Stores between April 30, 2022 and June 10, 2022. The product is identified by SKU 999109 and is sold in 0.5 oz bottles.
The recalled product
- Product
- MYLICON INFANT GAS DROPS 0.5 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Manufacturer
- Family Dollar Stores, Llc.
- Category
- Drug — Infant Medication
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:999109
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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