The Recall Desk
SevereFDA (Drugs)·D-0480-2019·Announced 2019-02-20

Promise Pharmacy Recalls Zinc Sulfate Injection Due to Sterility Concerns

Promise Pharmacy is recalling three vials 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 recalling three vials of Zinc Sulfate, 10mg/ml injection, 10ml vial, Rx Only. The recall is being conducted due to a lack of sterility assurance in the product.

The affected product is identified by Lot 10302018@7 with a beyond-use date of 12/14/2018. The recall covers three units that were distributed nationwide in the USA.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Affected units
3

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@7
  • 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.

See all 51 products in this recall →