Promise Pharmacy Recalls Folic Acid Injection Due to Sterility Concerns
Promise Pharmacy is recalling Folic Acid 5mg/ml injections because the product lacks sterility assurance. The recall covers nationwide distribution.
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 severity score per the rubric for significant injury risks or hospitalization reports.
Plain-English summary
Promise Pharmacy, LLC is recalling Folic Acid, 5mg/ml injection, 10ml vials, Rx Only. The recall is being conducted because the product lacks sterility assurance.
The affected product is identified by Lot 10302018@8 with a Beyond Use Date of 12/14/2018. The product was distributed nationwide in the USA.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Folic Acid, 5mg/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 Medication
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)
- Lot: 10302018@8
- 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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