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Recall Observatory FDA recall evidence

Drug product

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

D-0648-2021

June 08, 2021

Class III

Product summary

Firm
Prisma Health Outsourcing Facility
Event
Event 88097
Status
Terminated
Classification
Class III
Quantity
109 syringes
Official record key
drug-enforcement:D-0648-2021

Official wording

Reason: Labeling: Incorrect Exp. Date: Incorrect BUD.

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

Distribution pattern: Distributed in South Carolina

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect Exp. Date: Incorrect