Ketamine Sodium Chloride Injection (SCA Pharmaceuticals) – Sterility Concern (2020)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012
Brand
SCA Pharmaceuticals
Lot Codes / Batch Numbers
a) Lot # 1220023076, BUD 1/24/2021 & 1220023549, BUD 2/9/2021. b) Lot # 1220023040, BUD 1/19/2021, 1220023070, BUD 1/21/2021, 1220023105, BUD 1/25/2021, 1220023158, BUD 1/26/2021, 1220023315, BUD 2/1/2021, 1220023342, BUD 2/2/2021, 1220023431, BUD 2/4/2021, 1220023471, BUD 2/3/2021, 1220023481, BUD 2/4/2021 & 1220023509, BUD 2/8/2021.
Products Sold
a) Lot # 1220023076, BUD 1/24/2021 & 1220023549, BUD 2/9/2021. b) Lot # 1220023040, BUD 1/19/2021; 1220023070, BUD 1/21/2021; 1220023105, BUD 1/25/2021; 1220023158, BUD 1/26/2021; 1220023315, BUD 2/1/2021; 1220023342, BUD 2/2/2021; 1220023431, BUD 2/4/2021; 1220023471, BUD 2/3/2021; 1220023481, BUD 2/4/2021 & 1220023509, BUD 2/8/2021.
SCA Pharmaceuticals is recalling Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose S due to Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026