The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0474-2019·Announced 2019-02-20

Promise Pharmacy Recalls Procaine HCl Injection Due to Sterility Concerns

Promise Pharmacy, LLC is recalling 11 vials of Procaine HCl 2% injection due to a lack of sterility assurance. The product was 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. According to the rubric, FDA Class II recalls involving significant injury or hospitalization reports are rated as Severe (4). While specific injury reports are not detailed in the provided text, the agency classification of Class II for a sterile injection product involving sterility assurance issues aligns with the Severe category criteria for significant risk.

Plain-English summary

Promise Pharmacy, LLC is voluntarily recalling 11 vials of Procaine HCl, 2% injection, 10ml vial, Rx Only. The recall is being conducted due to a lack of sterility assurance in the product.

The affected lots are 11082018@4 with a best-use date of 12/23/2018, and 10302018@4 with a best-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 the recalling firm for further instructions.

The recalled product

Product
Procaine HCl, 2% injection, 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 (2)

  • Lots: 11082018@4 BUD: 12/23/2018
  • 10302018@4 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 →

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