Apotex Metformin Hydrochloride Tablet Recall [US]


Apotex Metformin Hydrochloride Tablet Recall [US]

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US FlagUS/Silver Spring: Apotex Corp., a Toronto, Ontario establishment, recalls certain batch/lots of Apotex Corp branded Metformin Hydrochloride Extended-Release Tablets from the American marketplace due to suspected N-Nitrosodimethylamine (“NDMA”) contamination in amounts above acceptable FDA levels with consequential risks of Cancer, severe illness and/or possible life-changing complications, all serious health hazards.

FDA: http://ht.ly/HmUE30qPhSK

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended-release-tablets

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Metformin medications are subject to this recall:

  • Metformin Hydrochloride Extended-Release Tablets, USP 500 mg tablets, sold in 100-count bottles with an NDC of 60505-0260-1

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

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

According to the FDA, the affected Metformin Hydrochloride Extended Release Tablets, USP, 500 mg batch/lots were distributed nationwide in the US directly to Wholesalers, Distributors, Retailers and Repackagers. You should neither serve nor consume the recalled Metformin medications identified above.

Pharmacies should cease dispensing these identified medications. Apotex Corp. is in a process of notifying its affected direct account Wholesaler, Distributor, Chain Distribution and Warehousing Chains via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product.

==> Never stop taking your prescription medications, including Metformin Hydrochloride Extended-Release Tablets, without the knowledge and approval of your personal physician or other MD familiar with your medical history, current health status and other drugs, medications and supplements you may be consuming. Failure to do so, may result in a serious drug interaction, side effect, complication, personal injury and/or death.

==> If you have a medical emergency, please contact 9-1-1, your closest hospital or emergency center equipped to properly treat N-Nitrosodimethylamine (“NDMA”) contamination.

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

Wholesalers, Distributors and Retailers should return the recalled product to the place of purchase. Anyone with an existing inventory of the product should quarantine the recalled lots immediately. Customers who purchased the impacted product directly from Apotex can call Inmar Rx Solutions at 1-888-985-9014 from 9:00 AM to 5:00 PM Eastern Standard Time, Monday to Friday, to arrange for their return.

Patients with questions regarding this recall can contact Apotex Corp. at 1-800-706-5575 from 8:30 AM to 5:00 PM Eastern Standard Time, Monday to Friday. You can also reach the company by e-mail at UScustomerservice@Apotex.com.

==> You should contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using this drug product.

==> To see other recalls and notifications caused by suspected faulty and/or dangerous Metformin Hydrochloride Extended Release Tablets, please search for “Metformin” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected N-Nitrosodimethylamine contamination contamination, please search for “NDMA” using the Search Box at the top of this page.

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

==> To see other recalls and notifications caused by suspected Carcinogenic contamination, please search for “Cancer” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 13129-2020
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:
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Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

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E. & O. E.

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