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Urgent Enforcement Added Final

Moxifloxacin ophthalmic solution recall due to assay out of trend

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Filed March 26th, 2026
Detected March 31st, 2026
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Summary

Health Canada issued a Type II recall for pms-MOXIFLOXACIN HCL 0.5% Ophthalmic Solution (DIN 02432218, Lot 240518) distributed nationally by Pharmascience. The recall was triggered because the assay is out of trend for the affected lot. Healthcare providers and consumers should verify if they have the affected product and consult with healthcare professionals before discontinuing use.

What changed

Health Canada has issued a Type II health product recall for a specific lot of pms-MOXIFLOXACIN ophthalmic solution (Lot 240518, DIN 02432218) manufactured by Pharmascience of Montreal, QC. The recall, identified as RA-81811, was triggered when testing revealed the assay is out of trend for this lot—a quality concern indicating the product's active ingredient concentration may not meet specifications. The recall depth extends to wholesalers and retailers nationwide.

Healthcare providers and patients should immediately verify whether they possess the affected lot 240518 of pms-MOXIFLOXACIN. The recall notice advises consulting a healthcare provider before discontinuing use of any affected product. Pharmascience should be contacted directly with questions, and any adverse reactions or health product safety complaints must be reported to Health Canada through the MedEffect Canada system. No specific compliance deadline was stated in the recall notice.

What to do next

  1. Verify if your pharmacy or healthcare facility has Lot 240518 of pms-MOXIFLOXACIN HCL 0.5% Ophthalmic Solution (DIN 02432218) in inventory
  2. Advise patients to consult their healthcare provider before discontinuing use of any affected product
  3. Report any adverse reactions or quality concerns related to this product to Health Canada via MedEffect Canada

Source document (simplified)

Health product recall

Moxifloxacin : assay out of trend

Brand(s)

pms-MOXIFLOXACIN

Last updated

2026-03-30

Summary

Product pms-MOXIFLOXACIN HCL 0.5% LIQ 3 mL Issue Health products - Product quality What to do Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.

Distribution National

Affected products

| Product Name | Market Authorization | Dosage Form | Strength | Lot number |
| --- | --- | --- | --- | --- |
| pms-MOXIFLOXACIN | DIN 02432218 | Ophthalmic solution | MOXIFLOXACIN HYDROCHLORIDE 0.5% | 240518 |

Issue

The assay is out of trend in the affected lot.

What you should do

  1. Verify if your product is affected.
  2. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
  3. Contact the recalling firm if you have any questions about the recall.
  4. Report any health product related side effects to Health Canada.
  5. Report any other health product safety complaints to Health Canada.

Additional information

Background

Depth of Recall: Wholesalers & Retailers

Details

Original published date:

2026-03-30

Alert / recall type Health product recall Category Health products - Drugs Companies Pharmascience
6111 avenue Royalmount, suite 100
Montréal QC
H4P 2T4

Published by Health Canada Audience General public Healthcare Industry Distribution National Recall class Type II Recall date

2026-03-26

Identification number RA-81811

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Classification

Agency
HC
Filed
March 26th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
RA-81811

Who this affects

Applies to
Drug manufacturers Healthcare providers Consumers
Industry sector
3254 Pharmaceutical Manufacturing 6211 Healthcare Providers
Activity scope
Drug Recall Quality Control
Threshold
Lot number 240518 only
Geographic scope
Canada CA

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Compliance frameworks
GxP
Topics
Healthcare Consumer Protection

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