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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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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