Promise Pharmacy Recalls Vitamin D3 Injections Due to Sterility Concerns
Promise Pharmacy is recalling specific lots of Vitamin D3 50,000iu/mL injections nationwide due to a lack of sterility assurance.
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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant injury or property damage reports or high-risk defects.
Plain-English summary
Promise Pharmacy, LLC is recalling 210 vials of Vitamin D3 50,000iu/mL, 5 mL injection, Rx Only. The recall is being conducted because of a lack of sterility assurance in the product.
The affected product was distributed nationwide in the USA. The specific lots involved are 09112018@10 (Best Use Date: 1/2/2019), 09212018@9 (Best Use Date: 1/12/2019), and 11132018@10 (Best Use Date: 2/27/2019).
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Manufacturer
- Promise Pharmacy, LLC
- Category
- Drug — Compounded Injectable
- Hazard
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 (3)
- Lots: 09112018@10 BUD: 1/2/2019
- 09212018@9 BUD: 1/12/2019
- 11132018@10 BUD: 2/27/2019
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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