Promise Pharmacy Recalls Niacinamide Injection Due to Sterility Concerns
Promise Pharmacy, LLC is recalling Niacinamide injection, 100mg/mL, 5mL vials due to a lack of sterility assurance. The product was distributed nationwide in the USA.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies the recall as FDA Class II. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving significant injury or property damage reports, or in this case, a structural defect in sterility assurance for an injectable drug.
Plain-English summary
Promise Pharmacy, LLC is recalling Niacinamide injection, 100mg/mL, 5mL vials, prescription only. The recall is being conducted due to a lack of sterility assurance. The affected product is identified by Lot 11022018@9 with a beyond-use date of 12/17/2018.
The recalled product was distributed nationwide in the USA. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for further instructions. The recalling firm is Promise Pharmacy, LLC, located at 31818 US Hwy 19N, Palm Harbor, FL 34684.
The recalled product
- Product
- Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Manufacturer
- Promise Pharmacy, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1
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)
- Lot: 11022018@9 BUD: 12/17/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 51 recalled by Promise Pharmacy, 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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