Baclofen/Bupivacaine Injectable Recalled Due to Sterility Concerns
The Compounding Shop is recalling Baclofen/Bupivacaine injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
The Compounding Shop, Inc. is recalling Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vials. The recall was initiated after FDA inspection findings resulted in concerns regarding quality control processes and the assurance of sterility for the product.
The affected product consists of 3 vials of 45 mL each. The recall covers all lots of this specific compounded injectable. The product was distributed in Florida, California, Minnesota, and Maine.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions on how to proceed.
The recalled product
- Product
- Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
- Manufacturer
- THE COMPOUNDING SHOP, INC.
- Category
- Drug — Injectable
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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