SCA Pharmaceuticals Recalls ePHEDrine Sulfate Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling 7,257 syringes of ePHEDrine Sulfate Injection due to a lack of assurance of sterility and potential defective syringe caps.
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 drug recalls involving potential sterility issues.
Plain-English summary
SCA Pharmaceuticals is recalling 7,257 syringes of ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection. The product is a prescription-only, 10 mL single-dose syringe manufactured by SCA Pharmaceuticals in Windsor, Connecticut.
The recall was initiated due to a lack of assurance of sterility and the potential for a defective syringe cap, which could result in a non-integral unit. The affected lots have expiration dates ranging from January 17, 2021, to February 10, 2021.
The product was distributed to hospitals nationwide. Healthcare facilities should stop using the affected product and contact SCA Pharmaceuticals for further instructions.
The recalled product
- Product
- ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 7,257
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 (16)
- Lot # 1220022996
- BUD 1/21/2021
- 1220023017
- BUD 1/20/2021
- 1220023021
- BUD 1/17/2021
- 1220023033
- BUD 1/19/2021
- 1220023146
- BUD 1/26/2021
- 1220023189
- BUD 1/27/2021 1220023242
- BUD 1/25/2021
- 1220023321
- BUD 2/2/2021
- 1220023357 BUD 2/10/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 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 32 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 →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide 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/Cyanocobalamin 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
- SevereSCA Pharmaceuticals Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2017-08-02
- ModerateSCA Pharmaceuticals Recalls Ephedrine Sulfate Syringes Due to Missing Labeling
FDA (Drugs) · 2018-01-17
- SevereSCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns
FDA (Drugs) · 2017-11-08
- SeverePharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- HighePHEDrine Injectable Syringes Recalled Over Sterility Assurance Gaps
FDA (Drugs) · 2023-08-09
- HighInjectable Phenylephrine Recall Due to Sterility Assurance Failure
FDA (Drugs) · 2024-04-03