SCA Pharmaceuticals Recalls Epinephrine Bitartrate Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling Epinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL due to 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, which corresponds to a Severe severity score per the rubric, particularly given the risk of infection from lack of sterility assurance.
Plain-English summary
SCA Pharmaceuticals is recalling Epinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, a prescription-only medication. The recall is being conducted because the product has a lack of assurance of sterility and has the potential to leak.
The affected lots are 20170502@31, 20170508@34, 20170508@70, and 20170512@15. The distribution pattern for this recall is nationwide. The product is manufactured by SCA Pharmaceuticals in Little Rock, Arkansas.
Healthcare providers and patients should stop using the recalled product and contact their healthcare provider for further instructions. Consumers should not use the product if it is leaking or if there are concerns about its sterility.
The recalled product
- Product
- NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0774-40
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injection
- 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 (4)
- Lots: 20170502@31 BUD: 7/16/2017
- 20170508@34 BUD: 7/22/2017
- 20170508@70 BUD: 7/22/2017
- 20170512@15 BUD: 7/26/2017
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