Severity
Moderate
FDA Drug recall · Reported March 27, 2019
Lack of Assurance of Sterility
Advanced Pharma Inc. recalled 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use s… - a moderate-severity action.
2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use s… was recalled by Advanced Pharma Inc. in March 27, 2019. Reason: Lack of Assurance of Sterility. Check the official notice for the remedy. Verify recall #D-1026-2019 with the FDA Drug before acting.
The recall
Advanced Pharma Inc. issued this moderate-severity FDA Drug recall-Lack of Assurance of Sterility.
Sourced from official FDA Drug enforcement records. Verify recall #D-1026-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-1026-2019) was formally reported on March 27, 2019, with the manufacturer initiating the action on March 13, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Advanced Pharma Inc. is listed as the recalling firm, operating out of Houston, TX. Federal records list the affected scope as 1540 syringes.
The documented reason for this recall is: Lack of Assurance of Sterility Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
1540 syringes
Related Recalls
6
0 from same agency
2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe, NDC: 42852-011-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1026-2019 |
| Date reported | March 27, 2019 |
| Date initiated | March 13, 2019 |
| Recalling firm | Advanced Pharma Inc. |
| Firm location | Houston, TX |
| Affected scope | 1540 syringes |
| Distribution | Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported March 27, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.