Promise Pharmacy Recalls Zinc Sulfate Injection Due to Sterility Concerns
Promise Pharmacy, LLC is recalling specific lots of Zinc Sulfate injection due to a lack of sterility assurance. The product was 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 and involves a lack of sterility assurance in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Promise Pharmacy, LLC is voluntarily recalling two 10 ml vials of Zinc Sulfate, 5mg/mL injection, prescription only. The recall is being conducted because of a lack of sterility assurance in the product.
The affected product is identified by Lot 11132018@9 with a beyond-use date of 12/28/2018. The recall was initiated by the U.S. Food and Drug Administration and classified as Class II.
The product was distributed nationwide in the USA. Patients 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
- Zinc Sulfate, 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
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: 11132018@9 BUD: 12/28/2018
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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