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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
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
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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