D-0648-2021 Class III Terminated
FDA drug recall D-0648-2021 was initiated by Prisma Health Outsourcing Facility on June 8, 2021 and is designated Class III. Reason for recall: Labeling: Incorrect Exp. Date: Incorrect BUD. The recall status is terminated (terminated September 21, 2021). Affected quantity: 109 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- June 23, 2021
- Initiation Date
- June 8, 2021
- Termination Date
- September 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.