Severity
Moderate
FDA Drug recall · Reported March 16, 2016
Lack of Assurance of Sterility
Hartley Medical Center Pharmacy, Incorporated recalled Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol. 22 ml syringe, Rx only, Hartley M… - a moderate-severity action.
Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol. 22 ml syringe, Rx only, Hartley M… was recalled by Hartley Medical Center Pharmacy, Incorporated in March 16, 2016. Reason: Lack of Assurance of Sterility. Check the official notice for the remedy. Verify recall #D-0736-2016 with the FDA Drug before acting.
The recall
Hartley Medical Center Pharmacy, Incorporated issued this moderate-severity FDA Drug recall-Lack of Assurance of Sterility.
Sourced from official FDA Drug enforcement records. Verify recall #D-0736-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0736-2016) was formally reported on March 16, 2016, with the manufacturer initiating the action on February 4, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Hartley Medical Center Pharmacy, Incorporated is listed as the recalling firm, operating out of Long Beach, CA. Federal records list the affected scope as 1 syringe.
The documented reason for this recall is: Lack of Assurance of Sterility Distribution data in the federal record shows the product reached: Nationwide. No foreign distribution.. 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
1 syringe
Related Recalls
6
0 from same agency
Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Lack of Assurance of Sterility
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0736-2016 |
| Date reported | March 16, 2016 |
| Date initiated | February 4, 2016 |
| Recalling firm | Hartley Medical Center Pharmacy, Incorporated |
| Firm location | Long Beach, CA |
| Affected scope | 1 syringe |
| Distribution | Nationwide. No foreign distribution. |
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 March 16, 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.