Severity
Moderate
FDA Drug recall · Reported March 20, 2024
Lack of Assurance of Sterility
Optikem International, Inc. recalled TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured… - a moderate-severity action.
TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured… was recalled by Optikem International, Inc. in March 20, 2024. Reason: Lack of Assurance of Sterility. Check the official notice for the remedy. Verify recall #D-0377-2024 with the FDA Drug before acting.
The recall
Optikem International, Inc. issued this moderate-severity FDA Drug recall-Lack of Assurance of Sterility.
Sourced from official FDA Drug enforcement records. Verify recall #D-0377-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0377-2024) was formally reported on March 20, 2024, with the manufacturer initiating the action on February 29, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Optikem International, Inc. is listed as the recalling firm, operating out of Denver, CO. Federal records list the affected scope as 9,936 bottles.
The documented reason for this recall is: Lack of Assurance of Sterility Distribution data in the federal record shows the product reached: Product distributed Nationwide in the USA. 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
9,936 bottles
Related Recalls
6
5 from same agency
TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-040-15.
Lack of Assurance of Sterility
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0377-2024 |
| Date reported | March 20, 2024 |
| Date initiated | February 29, 2024 |
| Recalling firm | Optikem International, Inc. |
| Firm location | Denver, CO |
| Affected scope | 9,936 bottles |
| Distribution | Product distributed Nationwide in the USA |
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.
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Safecor Health, LLC · 2026-05-27
IntegraDose Compounding Services LLC · 2026-05-27
Lupin Pharmaceuticals Inc. · 2026-05-27
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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 20, 2024. 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.