Promise Pharmacy Recalls Vitamin B Complex Vials Due to Sterility Concerns
Promise Pharmacy is recalling 204 vials of compounded Vitamin B Complex due to a lack of sterility assurance. The product was distributed nationwide.
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 and involves a lack of sterility assurance in an injectable compounded prescription, which poses a significant risk of serious injury or infection.
Plain-English summary
Promise Pharmacy, LLC is recalling 204 10 mL vials of Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine. The product is a prescription-only compounded medication manufactured by Promise Pharmacy Compounding Specialists in Palm Harbor, Florida. The recall is being conducted because of a lack of sterility assurance.
The affected lots are 10092018@4 with a best-use date of January 7, 2019, and 11122018@7 with a best-use date of February 10, 2019. The product was distributed nationwide in the United States.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 mg/mL 10 mL vial, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists, 31818 US Hwy 19N, Palm Harbor FL 34684
- Manufacturer
- Promise Pharmacy, LLC
- Category
- Drug — Compounded Prescription
- 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 (2)
- Lots: 10092018@4 BUD: 1/7/2019
- 11122018@7 BUD: 2/10/2019
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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