Severity
Moderate
FDA Drug recall · Reported November 9, 2016
Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
Pharmedium Services, LLC recalled Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDiu… - a moderate-severity action.
Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDiu… was recalled by Pharmedium Services, LLC in November 9, 2016. Reason: Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process …. Check the official notice for the remedy. Verify recall #D-0125-2017 with the FDA Drug before acting.
The recall
Pharmedium Services, LLC issued this moderate-severity FDA Drug recall-Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process ….
Sourced from official FDA Drug enforcement records. Verify recall #D-0125-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0125-2017) was formally reported on November 9, 2016, with the manufacturer initiating the action on October 12, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Pharmedium Services, LLC is listed as the recalling firm, operating out of Lake Forest, IL. Federal records list the affected scope as 1550 units.
The documented reason for this recall is: Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation. 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, 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.
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.
Severity
Moderate
Affected scope
1550 units
Related Recalls
6
5 from same agency
Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.
Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0125-2017 |
| Date reported | November 9, 2016 |
| Date initiated | October 12, 2016 |
| Recalling firm | Pharmedium Services, LLC |
| Firm location | Lake Forest, IL |
| Affected scope | 1550 units |
| 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 November 9, 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.