Cantrell Drug Company Recalls Fentanyl and Bupivacaine Bags for Sterility Concerns
Cantrell Drug Company is recalling specific lots of Fentanyl Citrate and Bupivacaine HCl bags due to a lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk contamination.
Plain-English summary
Cantrell Drug Company is recalling select lots of Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 100 mL bags. The recall is being conducted because the firm lacks assurance of the sterility of these sterile drug products.
The affected product is a single-dose bag intended for epidural use only in hospital or office settings. It is a prescription-only medication. The recall covers 2,889 bags distributed nationwide.
The specific lots affected are Lot 8942 with a beyond-use date of 2/19/2017, and Lot 9207 with a beyond-use date of 4/17/2017. Healthcare facilities and pharmacies should discontinue use of these specific lots and follow the recalling firm's instructions for return or disposal.
The recalled product
- Product
- Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 100 mL* Bag, Epidural Use Only, Single-Dose Bag, Hospital/Office Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-080-75
- Manufacturer
- Cantrell Drug Company
- Category
- Drug — Sterile Injectable
- Hazard
- Affected units
- 2,889
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: 8942 BUD: 2/19/2017
- Lot: 9207 BUD: 4/17/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 recalled by Cantrell Drug Company 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.
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