PREVACID Lansoprazole 15mg Capsules Recalled Due to Storage Conditions
Family Dollar Stores is recalling PREVACID 24HR Lansoprazole 15mg capsules distributed nationwide from April 30 to June 10, 2022, because the product was stored at improper temperatures in violation of manufacturing standards. Consumers should not use this product and should contact Family Dollar Stores for a refund.
What this means for you
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 involving improper storage temperature of a pharmaceutical product. While no illnesses or injuries have been reported, improper storage of medication presents a potential risk of harm by affecting drug stability and efficacy, satisfying the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Family Dollar Stores, LLC, is recalling PREVACID 24HR Lansoprazole 15mg capsules (SKU 903449) distributed to specific Family Dollar Store locations nationwide. The product was held at improper storage temperatures, constituting a violation of Current Good Manufacturing Practice (CGMP) standards.
The affected product was distributed between April 30, 2022, and June 10, 2022. The recall notice does not specify which store locations were affected or provide lot numbers for identification beyond the SKU.
Consumers who purchased this product should stop using it and contact Family Dollar Stores for information about refunds or replacements. Healthcare providers and patients taking this medication should consult with their pharmacist or doctor for alternative options if needed.
The recalled product
- Product
- PREVACID 24HR LANSOPRAZOLE 15MG CAP 14CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Manufacturer
- Family Dollar Stores, Llc.
- Category
- Drug
- Hazard
- improper-storage
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: 903449
Distribution
Distributed nationwide across the United States.
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