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D-0648-2021 Class III Terminated

Recalled by Prisma Health Outsourcing Facility — Simpsonville, SC

FDA drug recall D-0648-2021 was initiated by Prisma Health Outsourcing Facility on Jun 8, 2021 and is designated Class III. Reason for recall: Labeling: Incorrect Exp. Date: Incorrect BUD. The recall status is terminated (terminated Sep 21, 2021). Affected quantity: 109 syringes.

Recall Details

Product Type: Drugs
Report Date: Jun 23, 2021
Initiation Date: Jun 8, 2021
Termination Date: Sep 21, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 109 syringes

Product Description

Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded by Prisma Health Outsourcing Facility 1071 Holland Rd. Suite 2 Simpsonville, SC 29681. NDC: 73463-0100-01

Reason for Recall

Labeling: Incorrect Exp. Date: Incorrect BUD.

Distribution Pattern

Distributed in South Carolina

Code Information

Lots: K10521042 and K20521043 Exp. 08/31/2021.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0648-2021
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.