Injectable morphine-hydromorphone-bupivacaine mixture recalled for non-sterility
Med Shop Total Care Inc. is recalling a compounded injectable pain medication in Texas and Puerto Rico because the product failed to meet sterility standards. The recall affects lot 09292020@64.
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, which mandates a minimum severity score of 4. The hazard is non-sterility of an injectable medication, which can cause serious infections in patients receiving the drug.
Plain-English summary
Med Shop Total Care Inc. is recalling compounded morphine-hydromorphone-bupivacaine PF 13MG-19MG-2MG/ML injectable medication supplied in 21 mL syringes. The product was distributed in Texas and Puerto Rico.
The recall was initiated because the product failed to meet sterility requirements. Non-sterile injectable medications pose a risk of serious infection to patients who receive them.
The affected lot is 09292020@64, with a beyond-use date of 10/28/2020. Patients or healthcare providers who have this medication should not use it and should contact their pharmacy or healthcare provider for guidance on proper disposal or alternatives.
This is a voluntary recall initiated by the manufacturer on October 5, 2020, and was classified by FDA as a Class I recall. The recall was terminated on August 17, 2023.
The recalled product
- Product
- MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop 470 E. Loop 281 Longview, TX 75605
- Manufacturer
- Med Shop Total Care Inc.
- Hazard
- non-sterility
- infection-risk
- bacterial-contamination
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 (2)
- Lot #: 09292020@64
- BUD 10/28/2020
Distribution
Distribution scope not specified by the agency.
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