Good Sense Esomeprazole Acid Reducer Recalled for Improper Storage Conditions
Family Dollar Stores is recalling Good Sense Esomeprazole Acid Reducer 20mg bottles due to storage temperature deviations. Affected bottles were distributed between April 30 and June 10, 2022.
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 drug recall for CGMP violations involving storage temperature deviations. No illnesses or injuries reported. This is a risk-of-harm product where the hazard (loss of drug potency) is theoretical without reported injury, warranting a High severity score.
Plain-English summary
Good Sense Esomeprazole Acid Reducer 20mg (42-count) is being recalled by Family Dollar Stores, LLC due to storage temperature deviations during distribution.
Affected units were stored outside appropriate temperature conditions at certain Family Dollar Store locations between April 30, 2022 and June 10, 2022. These storage deviations represent violations of current good manufacturing practices (CGMP). Improperly stored medication may lose potency and effectiveness. The affected product SKU is 999850.
The recall applies to the United States. Consumers with affected bottles should stop using the product and consult a pharmacist or healthcare provider regarding replacement medication or refund options.
The recalled product
- Product
- GOOD SENSE ESOMEPRAZOLE ACID REDUCER 20MG 42CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Manufacturer
- Family Dollar Stores, Llc.
- Category
- Drug — Acid Reducer
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: 999850
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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