Fentanyl-Bupivacaine Injectable Recalled for Non-Sterility Risk
Med Shop Total Care is recalling one lot of Fentanyl-Bupivacaine HCL PF Injectable 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: The FDA classified this recall as Class I, the most serious classification level. Non-sterility in injectable pharmaceuticals poses serious risk of infection, and Class I recalls warrant a score of at least 4 per the rubric.
Plain-English summary
Med Shop Total Care Inc. is recalling Fentanyl-Bupivacaine HCL PF Injectable (3000mcg-12mg/mL, 21 mL syringe) due to non-sterility. The recalled product is Lot #09302020@67 with an expiration date of 10/29/2020, distributed in Texas and Puerto Rico.
The product is a prescription injectable medication. Non-sterility in injectable pharmaceuticals presents a risk of serious infection if the product is used. Consumers should stop using this medication and contact their healthcare provider immediately.
Healthcare providers and patients who have this product should not use it and should contact their pharmacy or healthcare provider for guidance. Questions about this recall can be directed to the FDA or the recalling firm.
The recalled product
- Product
- FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/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 / Anesthetic
- 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 #: 09302020@67 BUD: 10/29/2020
Distribution
Distribution scope not specified by the agency.
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