The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1429-2022·Announced 2022-08-31

MIRALAX 8.3 OZ Recalled Due to Improper Storage Temperature Conditions

Family Dollar Stores is recalling MIRALAX 8.3 OZ (SKU 902219) distributed nationwide from April 30 to June 10, 2022. The product was held outside appropriate storage temperatures, violating manufacturing standards.

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 classification indicates potential harm to a drug product. Storage temperature deviations present a risk-of-harm situation through potential compromise of drug efficacy and safety. This aligns with the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Family Dollar Stores, LLC is recalling MIRALAX 8.3 OZ that was distributed to select Family Dollar locations nationwide from April 30, 2022, through June 10, 2022. The affected product has SKU 902219.

The recall was issued because the product was held outside appropriate storage temperature conditions, constituting a deviation from Good Manufacturing Practice (CGMP) standards.

Consumers who have purchased this product should stop use and dispose of it appropriately. For additional information or questions, consumers may contact their local Family Dollar store.

The recalled product

Product
MIRALAX 8.3 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Manufacturer
Family Dollar Stores, Llc.
Category
Drug
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: 902219

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.

See all 100 products in this recall →

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