FDA Drug recall D-0773-2017
PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
- FDA Drug
- Class II
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class II recall of PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy by Key Pharmacy And Compounding Center, citing lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0773-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-18 |
| Published | 2017-05-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Key Pharmacy And Compounding Center |
| Distribution | US |
Product
PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Identifiers
| code_info | Lot # t11-21-2016@115, Exp 5/21/2017; t11-23-2016@109, Exp 5/27/2017; t12-13-2016@94, Exp 6/12/2017; t01-19-2017@85, Ex…Lot # t11-21-2016@115, Exp 5/21/2017; t11-23-2016@109, Exp 5/27/2017; t12-13-2016@94, Exp 6/12/2017; t01-19-2017@85, Exp 7/22/2017; 02/01/2017@116, Exp 7/31/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0773-2017%22
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