Injectable Drug Bupivacaine HCL-Baclofen PF Recalled for Non-Sterility
Med Shop Total Care Inc. is recalling a bupivacaine HCL-baclofen PF injectable drug (21 mL syringe, Lot #: 09282020@94) distributed in Texas and Puerto Rico due to non-sterility concerns.
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 FDA classified this recall as Class I, which mandates a minimum severity score of 4 per the rubric. The non-sterility hazard in an injectable drug poses serious risk of infection or other harm to patients, meeting the Severe classification for Class I drug recalls.
Plain-English summary
Med Shop Total Care Inc. is recalling bupivacaine HCL-baclofen PF injectable, 40 mg-4000 mcg/mL in 21 mL syringes, Rx only, due to non-sterility. The affected product was Lot #: 09282020@94 (Beyond Use Date: 10/27/2020) manufactured by Med Shop Total Care Inc., located at 470 East Loop 281, Longview, TX 75605.
The product was distributed to patients in Texas and Puerto Rico. The firm initiated this voluntary recall on October 5, 2020, and the FDA classified it as Class I on August 9, 2021. The recall was terminated on August 17, 2023.
Consumers who have received this product should contact their healthcare provider immediately regarding their use of the affected lot. Patients should not use the drug without consulting their physician.
This recall addresses a sterility defect that poses a potential risk to patients receiving the injection.
The recalled product
- Product
- BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
- Manufacturer
- Med Shop Total Care Inc.
- Category
- Drug — Injectable / Prescription
- Hazard
- non-sterility
- infection-risk
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@94 BUD: 10/27/2020
Distribution
Distribution scope not specified by the agency.
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