RecallRadar

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

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

AgencyFDA Drug
Recall numberD-0773-2017
ClassificationClass II
Statusterminated
Initiated2017-04-18
Published2017-05-24
Last updated2026-09-13 11:51 UTC
CompanyKey Pharmacy And Compounding Center
DistributionUS

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

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.