Promise Pharmacy Recalls Folic Acid Injection Due to Sterility Concerns
Promise Pharmacy, LLC is recalling Folic Acid Injection, 10 mg/mL, 10mL vials due to a lack of sterility assurance. The affected lots were distributed nationwide.
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 contamination.
Plain-English summary
Promise Pharmacy, LLC is recalling Folic Acid, Injection, 10 mg/mL, 10mL vials, which are prescription-only products. The recall is being conducted because of a lack of sterility assurance in the manufacturing process.
The affected product consists of 5 10ml vials per lot. The specific lot number is 11022018@4, with a beyond-use date of 12/17/2018. The recall was initiated by the U.S. Food and Drug Administration under recall number D-0472-2019.
The affected vials were distributed nationwide in the USA. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Folic Acid, Injection, 10 mg/mL, 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)
- Lots: 11022018@4 BUD: 12/17/2018
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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