The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0472-2019·Announced 2019-02-20

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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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.

See all 51 products in this recall →

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