Injectable drug recalled for non-sterility in Texas and Puerto Rico
Med Shop Total Care Inc. is recalling a Bupivacaine HCL-Lioresal PF injectable drug due to non-sterility concerns. The recall affects a 41 mL syringe product distributed in Texas and Puerto Rico.
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: This is an FDA Class I recall of a non-sterile injectable drug. Per the rubric, FDA Class I recalls that do not report fatalities are classified as Severe (score 4). Non-sterile injectables carry serious risk of infection and harm from contamination.
Plain-English summary
Med Shop Total Care Inc. is recalling Bupivacaine HCL-Lioresal PF Injectable 7.5mg-1625mcg/mL in a 41 mL syringe (Lot #09282020@38, Best Use Date 10/29/2020) due to non-sterility.
The product was distributed in Texas and Puerto Rico. This is a voluntary, firm-initiated recall that was reported to the FDA on August 18, 2021.
Non-sterile injectable drugs pose a serious health risk because they may contain harmful bacteria or other contaminants that can cause infection when injected. Consumers with this product should not use it and should contact their healthcare provider or pharmacist for instructions on safe disposal or replacement.
The recall status was terminated as of August 17, 2023.
The recalled product
- Product
- BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
- Manufacturer
- Med Shop Total Care Inc.
- Hazard
- non-sterility
- bacterial-contamination
- injection-site-infection
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)
- Lot #: 09282020@38 BUD: 10/29/2020
Distribution
Distribution scope not specified by the agency.
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