SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Bags Due to Leakage Risk
SCA Pharmaceuticals is voluntarily recalling specific lots of sterile fentanyl and bupivacaine admixture bags due to a potential for leakage that compromises sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (loss of sterility) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
SCA Pharmaceuticals, LLC is conducting a voluntary recall of 179 bags of Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bags. The recall is being issued due to a lack of assurance of sterility resulting from a potential for leakage in the packaging.
The affected product was distributed throughout the United States. The specific lots involved are identified by Lot # 20180327@27, 20180327@40, and 20180328@9, with an expiration date of 06/28/2018.
Healthcare providers and facilities should check their inventory for these specific lot numbers and discontinue use if found. Consumers should not use these products and should contact their healthcare provider for guidance.
The recalled product
- Product
- Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Sterile Admixtures
- Affected units
- 179
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 (4)
- Lot # 20180327@27
- 20180327@40
- 20180328@9
- Exp 06/28/2018
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 12 recalled by SCA Pharmaceuticals, LLC 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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