Public recall detail

Cromolyn eye drops: Out of specification (Antimicrobial efficacy)

2024-09-25

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Recall Safety notice
Quick summary

Quick summary: Cromolyn eye drops: Out of specification (Antimicrobial efficacy). Date: 2024-09-25.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Cromolyn eye drops: Out of specification (Antimicrobial efficacy). Date: 2024-09-25.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandPendopharm
ProductCromolyn eye drops
IssueHealth products - Product quality
Recall classType II
IdentificationRA-76185

Affected products

BrandPendopharm
ProductCromolyn eye drops
DIN / NPN / authorizationDIN 02009277
Dosage formSolution
StrengthCromolyn sodium 2%
Lot221021*, 231034*, 240517*, 230728, 230729, 240210, 240211 5 mL bottle (marked with *) or 10 mL

Issue

Out of specification antimicrobial efficacy analysis (AET) result obtained in stability for affected lots.

What you should do

  • Do not use the affected product. Return it to your local pharmacy for proper disposal.
  • Consult a health care professional if you have used this product and have health concerns.
  • Contact Pendopharm Division of Pharmascience Inc. by calling 1-888-550-6060 or emailing medinfo@pendopharm.com if you have questions about this recall.
  • Report any health product-related side effects or complaints to Health Canada.
Additional official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Drugs
CompaniesPENDOPHARM DIVISION OF PHARMASCIENCE INC 100, 6111 Royalmount Ave, Montréal, QC, H4P 2T4
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76185
Background{}
CompaniesPENDOPHARM DIVISION OF PHARMASCIENCE INC 100, 6111 Royalmount Ave, Montréal, QC, H4P 2T4
AudiencesGeneral public Healthcare Industry
Source updated2024-09-25

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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