Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported October 25, 2023
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Imprimis Njof, LLC recalled MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic So… - a low-severity action.
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic So… was recalled by Imprimis Njof, LLC in October 25, 2023. Reason: Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label cl…. Check the official notice for the remedy. Verify recall #D-0043-2024 with the FDA Drug before acting.
The recall
Imprimis Njof, LLC issued this low-severity FDA Drug recall-Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label cl….
- Low
- severity level
- Class III
- classification
- October 25, 2023
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0043-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0043-2024) was formally reported on October 25, 2023, with the manufacturer initiating the action on September 20, 2023. It is classified under Low severity (Class III), with a current status of Terminated. Imprimis Njof, LLC is listed as the recalling firm, operating out of Ledgewood, NJ. Federal records list the affected scope as 6,228 bags + 15,360 boxes.
The documented reason for this recall is: Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim. Distribution data in the federal record shows the product reached: Product was distributed to physician's offices 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.
Drugs & Medications recalls over time
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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
6,228 bags + 15,360 boxes
Related Recalls
6
5 from same agency
Product description
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
Reason for recall
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0043-2024 |
| Date reported | October 25, 2023 |
| Date initiated | September 20, 2023 |
| Recalling firm | Imprimis Njof, LLC |
| Firm location | Ledgewood, NJ |
| Affected scope | 6,228 bags + 15,360 boxes |
| Distribution | Product was distributed to physician's offices 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.
- Check the recall number (D-0043-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
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.
Frequently Asked Questions
What product was recalled? ▼
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05. Recalled by Imprimis Njof, LLC. Units affected: 6,228 bags + 15,360 boxes.
Why was this product recalled? ▼
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 25, 2023. Severity: Low. Recall number: D-0043-2024.
Where was the recalled product distributed? ▼
Distribution: Product was distributed to physician's offices nationwide..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0043-2024) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
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 October 25, 2023. 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.