Severity
Moderate
FDA Drug recall · Reported November 12, 2014
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a…
Oregon Compounding Centers, Inc. dba Creative Compounds recalled CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irr… - a moderate-severity action.
CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irr… was recalled by Oregon Compounding Centers, Inc. dba Creative Compounds in November 12, 2014. Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due…. Check the official notice for the remedy. Verify recall #D-0183-2015 with the FDA Drug before acting.
The recall
Oregon Compounding Centers, Inc. dba Creative Compounds issued this moderate-severity FDA Drug recall-Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due….
Sourced from official FDA Drug enforcement records. Verify recall #D-0183-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0183-2015) was formally reported on November 12, 2014, with the manufacturer initiating the action on October 6, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Oregon Compounding Centers, Inc. dba Creative Compounds is listed as the recalling firm, operating out of Wilsonville, OR. Federal records list the affected scope as 900 mL.
The documented reason for this recall is: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance t… Distribution data in the federal record shows the product reached: Oregon, Washington. 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
900 mL
Related Recalls
6
0 from same agency
CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irrigation, 30 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0183-2015 |
| Date reported | November 12, 2014 |
| Date initiated | October 6, 2014 |
| Recalling firm | Oregon Compounding Centers, Inc. dba Creative Compounds |
| Firm location | Wilsonville, OR |
| Affected scope | 900 mL |
| Distribution | Oregon, Washington |
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 November 12, 2014. 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.