SCA Pharmaceuticals Recalls Bupivacaine HCl Due to Sterility Concerns
SCA Pharmaceuticals is recalling Bupivacaine HCl 0.1% 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance for an injectable drug represents a significant risk of harm, aligning with the Severe criteria for Class II recalls with potential for serious adverse health consequences.
Plain-English summary
SCA Pharmaceuticals is voluntarily recalling Bupivacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative Free. The recall is being conducted because the product has a lack of assurance of sterility and has the potential to leak.
The affected product is identified by NDC# 70004-0060-40. Specific lots involved in the recall include 20170429@33 with a best-use date of 7/28/2017, and 20170503@23 with a best-use date of 8/1/2017. The distribution pattern for this product is nationwide.
Healthcare providers and patients should discontinue use of the affected lots and contact SCA Pharmaceuticals or their supplier for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative Free (Waste From 250 mL Bag), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0060-40
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Anesthetic
- Hazard
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)
- Lots: 20170429@33 BUD: 7/28/2017
- 20170503@23 BUD: 8/1/2017
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.
See all 30 products in this recall →Related recalls
Same manufacturer · SCA Pharmaceuticals
See all →- HighSCA Pharmaceuticals Fentanyl-Bupivacaine Injectable Recall Due to Manufacturing Deviations
FDA (Drugs) · 2023-08-02
- ModerateFDA recalls Oxytocin product for low potency nationwide
FDA (Drugs) · 2023-05-03
- ModerateFentanyl Injection Syringes Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2023-03-08
- ModerateNorepinephrine Injection Recalled Nationwide for Manufacturing Quality Deviations
FDA (Drugs) · 2022-05-11
- ModerateDrug recall: fentanyl and bupivacaine injectable solution manufacturing deviations
FDA (Drugs) · 2022-05-11
Same hazard · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15