Time-Cap Labs Metformin Hydrochloride Tablet Recall [US]


Time-Cap Labs Metformin Hydrochloride Tablet Recall [US]

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US FlagUS/Silver Spring: Marksans Pharma Limited, a Verna, Goa, India establishment, recalls certain batch/lots of Time-Cap Labs, Inc. 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/upL630qNRGM

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/marksans-pharma-limited-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended-release

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, sold in 100-count bottles with a batch/lot designation of XP9004, an expiry date of 12/2020 and an NDC of 49483-623-01

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. Marksans Pharma is notifying its distributors and customers by issuing notification letters and a press release, and is arranging for return and/or replacement of recalled product batch/lots. Distributors/retailers that have the recalled Metformin Hydrochloride Extended-Release Tablets, USP 500mg, batch/lot XP9004 should return the medications to the place of purchase.

==> Never stop taking your prescription medications, including N-Nitrosodimethylamine (“NDMA”), 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 Extended Release Tablets, please search for “Metformin” using the Search Box at the top of this page.

If you have any further questions, comments or complaints about this recall, please contact Ms. Irene McGregor, Vice President, Regulatory Affairs) of Time-Cap Labs, Inc. in Farmingdale, New York at +1-631-753-9090, extension 160, from 8:00 AM to 5:00 PM Eastern Standard Time, Monday to Friday or e-mail at imcgregor@timecaplabs.com.

==> 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 Marksans Pharma Limited, please search for “Marksans” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Time-Cap Labs, Inc., please search for “Time-Cap” 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: 13112-2020
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:
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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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