Topical ointment recall due to improper storage temperature conditions
Family Dollar Stores is recalling AD PREV OINT ORIG 4 OZ due to improper storage conditions that may affect product quality. Products distributed nationwide from April 30 through June 10, 2022 are affected.
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 drug recall involving improper storage temperature conditions (CGMP deviation). The product represents a risk of harm through potential loss of potency or efficacy due to temperature excursions, though no illnesses or injuries have yet been reported.
Plain-English summary
Family Dollar Stores, LLC is recalling AD PREV OINT ORIG 4 OZ, a topical ointment product, due to manufacturing control deviations.
The FDA found that the product was held outside of appropriate storage temperature conditions during distribution. This deviation from Good Manufacturing Practice (CGMP) standards could compromise the potency and efficacy of the ointment.
The affected product was distributed nationwide through specific Family Dollar Store locations between April 30, 2022 and June 10, 2022. The product SKU is 900018.
Consumers who have purchased this product should stop using it and return it to the place of purchase. If you have questions about this recall, contact Family Dollar Stores, LLC or the FDA.
The recalled product
- Product
- AD PREV OINT ORIG 4 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Manufacturer
- Family Dollar Stores, Llc.
- Category
- Drug — Topical Ointment
- Hazard
- improper-storage-temperature
- 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)
- SKUs: 900018
Distribution
Distributed nationwide across the United States.
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