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.
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 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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