DermOtic Oil Ear Drops Recall [Canada]


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DermOtic Oil Ear Drops Recall [Canada]

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Canada/Ottawa: Hill Dermaceuticals Inc., a Mississauga, Ontario establishment, recalls numerous batch/lots of DermOtic Oil Ear Drops from the Canadian marketplace due to suspected Glass Fragment Contamination and consequential risks of outer ear injury, tympanic membrane laceration, infection hearing damage, all serious health and safety hazards.

HCSC: http://ht.ly/WmHi30rJf7L

Direct link: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75709r-eng.php

Additional information:
Health Canada/Santé Canada (“HCSC”) reports the following Ear Drops are subject to this recall:

  • DermOtic Oil Ear Drops, sold with a strength of Fluocinolone Acetonide at 0.01% w/v, a DIN of 02300559 and the following batch/lot numbers:
    • 19K036E
    • 19L039D
    • 20A001D
    • 20A003F
    • 20A003G
    • 20C013F
    • 20E025E
    • 20G037D
    • 20H041G
    • 20J043G
    • 20K050E
    • 20L055F
    • 20L055H
    • 21C015D
    • 21C018F

Please consult the photograph above for details of the product’s packaging, design and retail presentation.

==> No barcodes, UPCs, item numbers, best-before date codes, manufacturing date codes, production dates, expiry dates, registration numbers, agency approval designations or other identification numbers were listed with this recall notification.

These DermOtic Oil Ear Drops were known to be marketed, distributed and sold from medical retailers and wholesalers in all Canadian provinces although it is always possible these food products had wider distribution within the country. When in doubt, please contact the manufacturer for specific product information.

According to the company, DermOtic Oil Ear Drops (Fluocinolone Acetonide Otic Solution), 0.01% w/v are indicated for moderate to severe Chronic Eczematous External Otitis (an inflammatory condition of the external ear) in adults and children 12 years and older. This medication is NOT to be used on the face or eyes.

Please note: Physicians and other healthcare professionals can download and read the Product Monograph for Dermotic Oil Ear Drops here: https://www.hillderm.com/wp-content/uploads/canada-products/derm-otic-en.pdf.

According to Health Canada, Hill Dermaceuticals has recalled numerous batch/lots of DermOtic Oil Ear Drops from the Canadian marketplace due to suspected Glass Fragment Contamination.

If you believe you have purchased or have in your possession any of the recalled DermOtic Oil Ear Drops, please do not use them. Instead, kindly return the product to the store, pharmacist, dispensary, distributor or outlet where you purchased it for a full refund.

==> Never depend on your senses of sight to confirm drug poisoning or contamination. If in doubt about the safety of any drug, return it to your seller for refund.

Disposal of this product must be in accordance with local municipal hazardous waste requirements to protect your personal safety, the local drinking water supply and the ecosystem. Please consult your local municipal waste authority for the correct steps for your particular community.

If you have any further questions, comments or complaints about this recall, please contact Hill Dermaceuticals toll-free at 1-800-344-5707 (US) or +1-407-323-1887 (Sanford, Florida headquarters) from 8:30 AM to 5:00 PM Eastern Standard Time, Monday to Friday . You cal also reach the company on the Web at https://www.hillderm.com/contact/ or by e-mail at contact@hillderm.com.

Please note: the Canada Consumer Product Safety Act prohibits recalled products from being redistributed, sold or even given away in Canada.

==> To see other recalls and notifications caused by suspected contaminated, adulterated or mislabeled Ear Drops, please search for “drug” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Glass Fragment contamination, please search for “glass” or more generically, “fragment” using the Search Box at the top of this page.

==> To see other recalls and notifications concerning Laceration hazards, please search for “Laceration” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Hill Dermaceuticals Inc., please search for “Hill Dermaceuticals” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the DermOtic brand, please search for “DermOtic” using the Search Box at the top of this page.

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More information about this recall:
HCSC ID number: RA-75709
Recalls Direct RIN: 14491-2021
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe product you purchased in Canada [external: new window opens]:
==> http://www.hc-sc.gc.ca/cps-spc/advisories-avis/incident/index-eng.php
Search for a recalled product on the Health Canada Web site [external: new window opens]:
==> http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php

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E. & O. E.

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