SCA Pharmaceuticals Recalls Epinephrine HCl Due to Sterility Concerns
SCA Pharmaceuticals is recalling Epinephrine HCl 4 mg in 0.9% Sodium Chloride 250 mL due to a lack of assurance of sterility and potential for leaking.
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 for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
SCA Pharmaceuticals is recalling Epinephrine HCl 4 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 20170508@51 with a best use date of 9/10/2017, and 20170503@17 with a best use date of 9/5/2017. The product was distributed nationwide. The National Drug Code (NDC) for the product is 70004-0613-40.
Healthcare providers and patients should stop using the recalled product and contact SCA Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- Product
- EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0613-40
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
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: 20170508@51 BUD: 9/10/2017
- 20170503@17 BUD: 9/5/2017
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 · sterility
See all →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- HighPharmaceutical Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2024-04-03
- HighSCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Leakage Risk
FDA (Drugs) · 2018-07-11
- SevereSCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Sterility Concerns
FDA (Drugs) · 2018-07-11
- SevereSCA Pharmaceuticals Recalls Phenylephrine Bags Due to Sterility Concerns
FDA (Drugs) · 2018-07-11
- SevereSCA Pharmaceuticals Recalls Phenylephrine Injectable Bags Due to Leaking
FDA (Drugs) · 2017-06-07
- SevereSCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns
FDA (Drugs) · 2017-11-08