Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported July 10, 2013
Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a…
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Baxter Healthcare Corp. recalled Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfie… - a moderate-severity action.
Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfie… was recalled by Baxter Healthcare Corp. in July 10, 2013. Reason: Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential adm…. Check the official notice for the remedy. Verify recall #D-629-2013 with the FDA Drug before acting.
The recall
Baxter Healthcare Corp. issued this moderate-severity FDA Drug recall-Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential adm….
- Moderate
- severity level
- 172K units
- affected scope
- Class II
- classification
- July 10, 2013
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-629-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-629-2013) was formally reported on July 10, 2013, with the manufacturer initiating the action on May 21, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Baxter Healthcare Corp. is listed as the recalling firm, operating out of Deerfield, IL. Federal records list the affected scope as 172,296 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred duri… Distribution data in the federal record shows the product reached: Nationwide & Puerto Rico. 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, 5 from FDA Drug - 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.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications 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.
Affected scope
172,296 units
Related Recalls
6
5 from same agency
Product description
Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48
Reason for recall
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-629-2013 |
| Date reported | July 10, 2013 |
| Date initiated | May 21, 2013 |
| Recalling firm | Baxter Healthcare Corp. |
| Firm location | Deerfield, IL |
| Affected scope | 172,296 units |
| Distribution | Nationwide & Puerto Rico |
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-629-2013) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48. Recalled by Baxter Healthcare Corp.. Units affected: 172,296 units.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 10, 2013. Severity: Moderate. Recall number: D-629-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide & Puerto Rico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-629-2013) 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
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
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 July 10, 2013. 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.