Severity
Moderate
FDA Drug recall · Reported August 12, 2015
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
The Apothecary Shoppe LLC recalled S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compoun… - a moderate-severity action.
S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compoun… was recalled by The Apothecary Shoppe LLC in August 12, 2015. Reason: Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the ti…. Check the official notice for the remedy. Verify recall #D-1290-2015 with the FDA Drug before acting.
The recall
The Apothecary Shoppe LLC issued this moderate-severity FDA Drug recall-Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the ti….
Sourced from official FDA Drug enforcement records. Verify recall #D-1290-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-1290-2015) was formally reported on August 12, 2015, with the manufacturer initiating the action on June 26, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. The Apothecary Shoppe LLC is listed as the recalling firm, operating out of Tulsa, OK. Federal records list the affected scope as 98 mL.
The documented reason for this recall is: Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. Distribution data in the federal record shows the product reached: Oklahoma. 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
98 mL
Related Recalls
6
5 from same agency
S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1290-2015 |
| Date reported | August 12, 2015 |
| Date initiated | June 26, 2015 |
| Recalling firm | The Apothecary Shoppe LLC |
| Firm location | Tulsa, OK |
| Affected scope | 98 mL |
| Distribution | Oklahoma |
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 August 12, 2015. 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.