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.
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, 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
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.
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