Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported December 28, 2016
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
Non-Sterility: failed sterility test result.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Guardian Pharmacy Services recalled Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syring… - a critical-severity action.
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syring… was recalled by Guardian Pharmacy Services in December 28, 2016. Reason: Non-Sterility: failed sterility test result.. Check the official notice for the remedy. Verify recall #D-0211-2017 with the FDA Drug before acting.
The recall
Guardian Pharmacy Services issued this critical-severity FDA Drug recall-Non-Sterility: failed sterility test result..
- Critical
- severity level
- Class I
- classification
- December 28, 2016
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0211-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0211-2017) was formally reported on December 28, 2016, with the manufacturer initiating the action on September 23, 2016. It is classified under Critical severity (Class I), with a current status of Terminated. Guardian Pharmacy Services is listed as the recalling firm, operating out of Dallas, TX. Federal records list the affected scope as 180 syringes.
The documented reason for this recall is: Non-Sterility: failed sterility test result. Distribution data in the federal record shows the product reached: Two medical facilities in TX. 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.
Medical Devices recalls over time
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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
180 syringes
Related Recalls
6
0 from same agency
Product description
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
Reason for recall
Non-Sterility: failed sterility test result.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0211-2017 |
| Date reported | December 28, 2016 |
| Date initiated | September 23, 2016 |
| Recalling firm | Guardian Pharmacy Services |
| Firm location | Dallas, TX |
| Affected scope | 180 syringes |
| Distribution | Two medical facilities in TX |
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.
- Check the recall number (D-0211-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
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.
Frequently Asked Questions
What product was recalled? ▼
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only. Recalled by Guardian Pharmacy Services. Units affected: 180 syringes.
Why was this product recalled? ▼
Non-Sterility: failed sterility test result.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 28, 2016. Severity: Critical. Recall number: D-0211-2017.
Where was the recalled product distributed? ▼
Distribution: Two medical facilities in TX.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0211-2017) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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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 December 28, 2016. 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.