PlainRecalls
ModerateClass IITerminated

FDA Drug recall · Reported May 31, 2017

Sufentanil Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Recall #
D-0808-2017
Initiated
February 22, 2017
Verify with FDA Drug →
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Advanced Pharma Inc. recalled Sufentanil Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of… - a moderate-severity action.

Sufentanil Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of… was recalled by Advanced Pharma Inc. in May 31, 2017. Reason: Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.. Check the official notice for the remedy. Verify recall #D-0808-2017 with the FDA Drug before acting.

The recall

Advanced Pharma Inc. issued this moderate-severity FDA Drug recall-Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex..

Moderate
severity level
Class II
classification
May 31, 2017
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0808-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts. Distribution scope (see Distribution below) 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, 6 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 - 14,472 drugs & medications recalls on record

05001,0001,5002,000 2006201220152018202120242026 448
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

Sufentanil Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Reason for recall

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-0808-2017
Date reported May 31, 2017
Date initiated February 22, 2017
Recalling firm Advanced Pharma Inc.
Firm location Houston, TX
Affected scope Not disclosed
Distribution U.S. 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.

  • Check the recall number (D-0808-2017) 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.
  • 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?
Sufentanil Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054. Recalled by Advanced Pharma Inc..
Why was this product recalled?
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 31, 2017. Severity: Moderate. Recall number: D-0808-2017.
Where was the recalled product distributed?
Distribution: U.S. Nationwide.
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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: FDA Drug, reported May 31, 2017. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026