Promise Pharmacy Recalls Pyridoxine HCl Injection Due to Sterility Concerns
Promise Pharmacy, LLC is recalling 8 vials of Pyridoxine HCl Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.
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 3/5 (High).
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: The recall involves a risk-of-harm product (injection with sterility issues) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Promise Pharmacy, LLC is recalling 8 vials of Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only. The recall is being conducted due to a lack of sterility assurance. The affected product is identified by Lot 10302018@3 with a Beyond Use Date of 12/14/2018.
The product was distributed nationwide in the USA. The source text does not specify the number of units distributed or the specific states affected beyond the nationwide scope.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for instructions on return or disposal. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Manufacturer
- Promise Pharmacy, LLC
- Category
- Drug — 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 (1)
- Lot: 10302018@3 BUD: 12/14/2018
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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