ZzzQuil Night Pain Berry Recalled Due to Improper Storage
ZzzQuil Night Pain Berry 12 FL OZ distributed to Family Dollar Stores from April 30 through June 10, 2022, was held outside appropriate storage temperature conditions, which may compromise medication stability and integrity.
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 recall with no reported illnesses or injuries. Improper storage temperature of a drug represents a material risk-of-harm to medication stability and effectiveness, warranting a High severity score.
Plain-English summary
ZzzQuil Night Pain Berry 12 FL OZ is an over-the-counter sleep aid and pain reliever product distributed to Family Dollar Stores. The FDA recalled the product due to Current Good Manufacturing Practice (CGMP) deviations.
Specifically, the affected product was held outside appropriate storage temperature conditions during the distribution period of April 30, 2022 through June 10, 2022. Improper storage temperatures may affect the stability and therapeutic efficacy of the medication.
The product (SKU 903452) was distributed nationwide to specific Family Dollar Store locations. The recalling firm is Family Dollar Stores, LLC.
The recalled product
- Product
- ZZZQUIL NIGHT PAIN BERRY 12 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Manufacturer
- Family Dollar Stores, Llc.
- Category
- Drug — Sleep Aid
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: 903452
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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