Injectable Drug Sufentanil-Bupivacaine-Baclofen Recalled for Non-Sterility
Med Shop Total Care Inc. is recalling a 41 mL injectable drug combination due to non-sterility concerns. The affected product was 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 for a sterile injectable drug product with a non-sterility hazard. Non-sterile injectables pose serious risk of infection and systemic complications in patients receiving intrathecal or epidural administration, meeting the Severe threshold even without reported illnesses documented in this source.
Plain-English summary
Med Shop Total Care Inc. is recalling Sufentanil-Bupivacaine-Baclofen PF 25MCG-12.5MG-750MCG/ML injectable in 41 mL syringes due to non-sterility. The recalled lot is #09302020@47 with a beyond-use date of 10/28/2020.
The product was distributed to Texas and Puerto Rico. This is a Class I recall initiated voluntarily by the firm on October 5, 2010, with notification to customers made through multiple channels including email, fax, letter, press release, telephone, and direct visits.
Patients who have received this medication should consult their healthcare provider immediately. Healthcare providers and patients should not use any remaining product from this lot and should contact Med Shop Total Care Inc. at the address listed on the product for further information.
The recalled product
- Product
- SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 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
- 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 #: 09302020@47 BUD 10/28/2020
Distribution
Distribution scope not specified by the agency.
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