Vaginal Contraceptive Foam (2019-12-23)

Starting date:

December 23, 2019

Posting date:

January 20, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72131

Last updated: 2020-01-21

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  Reason
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  Affected products

Affected Products

Vaginal Contraceptive Foam

Reason

Possible leaking canisters, rendering the product unusable. CMO and tester, Pharmasol Corporation, initiated OOS Investigation (Attachment-A Leak test Investigation) in July 2017 on behalf of the Apothecus Pharmaceutical Corp for VCF Foam Batches 31560 and 31561. Investigation was concluded and product released into distribution in August 2017; however, Pharmasol later dismissed the original OOS root cause. Apothecus voluntarily recalling these questioned lots.

Affected products