SCA Pharmaceuticals Recalls Bupivacaine HCl Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling Bupivacaine HCl 0.2% bags because they may leak and lack sterility assurance.
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, particularly given the risk of infection from a lack of sterility assurance in a medical product.
Plain-English summary
SCA Pharmaceuticals is recalling Bupivacaine HCl 0.2% in 0.9% Sodium Chloride 250 mL bags, preservative free. The product is identified by NDC 70004-0066-40, Lot 20170501@69, and has a beyond-use date of July 30, 2017.
The recall was initiated due to a lack of assurance of sterility and the potential for the product to leak. This issue poses a risk to patients who may receive the medication.
The affected product was distributed nationwide. Healthcare providers and patients should stop using the recalled product and contact SCA Pharmaceuticals for further instructions or replacement.
The recalled product
- Product
- BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free (Total Dose Bupivacaine 500 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0066-40
- 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: 20170501@69 BUD: 7/30/2017
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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