Jet Alert Tablets Recalled for Improper Storage Temperature Conditions
Jet Alert stimulant tablets distributed nationwide from April to June 2022 are being recalled due to improper storage temperature conditions that may affect product safety and efficacy.
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 FDA Class II recall involves a drug product held outside appropriate storage conditions, representing a potential risk to product safety and efficacy. No illnesses or injuries have been reported, but the hazard meets the threshold for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Jet Alert stimulant tablets (30-count packages) distributed to specific Family Dollar Stores nationwide between April 30, 2022 and June 10, 2022 are being recalled. The product was identified as having been held outside appropriate storage temperature conditions, which may affect the safety and efficacy of the medication.
The manufacturer, Family Dollar Stores, Llc., initiated this Class II recall in response to identified CGMP (Current Good Manufacturing Practice) deviations. Consumers who purchased Jet Alert tablets with SKU 914001 during the affected distribution window should stop using the product.
Consumers who have purchased affected Jet Alert tablets should discontinue use and consider consulting a healthcare provider if they have questions about their use of this product. No illnesses or injuries related to this recall have been reported at this time.
The recalled product
- Product
- JET ALERT TABLET 30 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Manufacturer
- Family Dollar Stores, Llc.
- Category
- Drug — Stimulant Tablet
- Hazard
- improper-storage
- cgmp-deviation
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: 914001
Distribution
Distributed nationwide across the United States.
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