D-1069-2018 Class II Terminated

Recalled by Guardian Pharmacy Services — Dallas, TX

FDA drug recall D-1069-2018 was initiated by Guardian Pharmacy Services on May 17, 2018 and is designated Class II. Reason for recall: Lack of sterility assurance. The recall status is terminated (terminated Nov 25, 2020). Affected quantity: 250 10-ml syringes.

Recall Details

Product Type
Drugs
Report Date
Aug 15, 2018
Initiation Date
May 17, 2018
Termination Date
Nov 25, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
250 10-ml syringes

Product Description

Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Reason for Recall

Lack of sterility assurance.

Distribution Pattern

Texas

Code Information

Lots: 58641:42 Use By: 06/04/2018; 58775:42 Use By: 06/16/2018; 59077:42 Use By: 07/17/2018

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1069-2018
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

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