Injectable drug recalled due to non-sterility concern
Med Shop Total Care is recalling morphine-bupivacaine-fentanyl injectable syringes due to non-sterility. The affected lot 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: The FDA classified this as a Class I recall, which mandates a minimum severity score of 4. Non-sterility in an injectable drug product poses significant risk of serious infection or harm to patients.
Plain-English summary
Med Shop Total Care Inc. is recalling morphine-bupivacaine-fentanyl PF 30MG-15MG-2000MCG/ML injectable 21 mL syringes. The reason for recall is non-sterility.
The affected product is Lot #09302020@57 with a Beyond Use Date of 10/29/2020. Distribution occurred in Texas and Puerto Rico.
Consumers who have received this product should not use it and should contact their healthcare provider or pharmacy. The firm initiated this recall voluntarily. The recall was initiated on October 5, 2020.
The recalled product
- Product
- MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 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
- Hazard
- non-sterility
- injection-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 #: 09302020@57 BUD 10/29/2020
Distribution
Distribution scope not specified by the agency.
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