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.
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
Part of a larger recall action
This product is one of 14 recalled by Med Shop Total Care 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.
See all 14 products in this recall →Related recalls
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