SCA Pharmaceuticals Recalls Bupivacaine HCl Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling specific lots of Bupivacaine HCl 0.125% bags due to a lack of assurance of sterility and potential for leaking.
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 and involves a lack of assurance of sterility in a medical product, which poses a risk of serious adverse health consequences such as infection, meeting the criteria for a Severe rating.
Plain-English summary
SCA Pharmaceuticals is recalling Bupivacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free (NDC# 70004-0062-40). The recall is limited to Lot 20170502@32 with a beyond-use date of 7/31/2017. The product is distributed nationwide.
The recall was initiated because the product has a lack of assurance of sterility and has the potential to leak. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected product and contact SCA Pharmaceuticals for further instructions. Consumers should not use the recalled bags and should return them to the pharmacy or healthcare provider where they were obtained.
The recalled product
- Product
- BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free (Total Dose Bupivacaine 312.5 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0062-40
- Manufacturer
- SCA Pharmaceuticals
- 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: 20170502@32 BUD: 7/31/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by SCA Pharmaceuticals 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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