The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-562-2013·Announced 2013-06-12

FDA Recalls Procaine Injectable Due to Sterility Concerns

The FDA is recalling Procaine 1% Injectable vials due to quality control concerns regarding sterility assurance. The affected products were distributed in four states.

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 potential harm or quality control failures involving injectable medications.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, Inc. in St. Petersburg, Florida. The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used to ensure the sterility of the product.

The affected units consist of 2 vials of 250 mL and 26 vials of 100 mL. The products were distributed in Florida, California, Minnesota, and Maine. The recall covers all lots of the specified product.

Healthcare providers and patients should stop using the recalled product and contact The Compounding Shop, Inc. for further instructions or a replacement. Consumers should not use the product if they have any questions about its safety or sterility.

The recalled product

Product
Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Manufacturer
THE COMPOUNDING SHOP, INC.
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)

  • All Lots

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 25 recalled by THE COMPOUNDING SHOP, INC. 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 25 products in this recall →

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