Amneal Metformin Hydrochloride Tablet Recall [US]


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US FlagUS/Silver Spring: Amneal Pharmaceuticals LLC, a Bridgewater, New Jersey establishment, recalls all current batch/lots of 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/pU8030qNxkW

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended

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

The Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, subject to the recall, are identified by the NDC numbers stated on the product label.

  • Metformin HCl Extended Release Tablets, as follows:
    • Metformin HCl Extended Release Tablets, USP, 500 mg, sold in 100-count bottles with an NDC designation of 53746-178-01
    • Metformin HCl Extended Release Tablets, USP, 500 mg, sold in 500-count bottles with an NDC designation of 53746-178-05
    • Metformin HCl Extended Release Tablets, USP, 500 mg, sold in 1000-count bottles with an NDC designation of 53746-178-10
    • Metformin HCl Extended Release Tablets, USP, 90 mg, sold in 1000-count bottles with an NDC designation of 53746-178-90
    • Metformin HCl Extended Release Tablets, USP, sold in 90-count bottles with an NDC designation of 53746-178-Bulk
    • Metformin HCl Extended Release Tablets, USP, sold in 90-count bottles with an NDC designation of 65162-178-09
    • Metformin HCl Extended Release Tablets, USP, sold in 100-count bottles with an NDC designation of 65162-178-10
    • Metformin HCl Extended Release Tablets, USP, sold in 1000-count bottles with an NDC designation of 65162-178-11
    • Metformin HCl Extended Release Tablets, USP, sold in 500-count bottles with an NDC designation of 65162-178-50
  • Metformin HCl Extended Release Tablets, USP, 750 mg
    • Metformin HCl Extended Release Tablets, USP, 750 mg, sold in 100-count bottles with an NDC designation of 53746-179-01
    • Metformin HCl Extended Release Tablets, USP, 750 mg, sold in 100-count bottles with an NDC designation of 53746-179-Bulk
    • Metformin HCl Extended Release Tablets, USP, 750 mg, sold in 100-count bottles with an NDC designation of 65162-179-10

Please consult the photograph above for details of the drug’s packaging, design and retail/wholesale presentation. Additional images of the recalled Metformin Hydrochloride Extended Release Tablets can be found on the Web site above.

==> No barcodes, UPCs, DINs, item numbers, best-before date codes, manufacturing date codes, production dates, expiry 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 and 750 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. Amneal is also notifying Retailers via mail (UPS Standard Overnight) who have been provided Amneal’s Metformin Hydrochloride Extended Release Tablets, USP, 500 mg or 750 mg, which will include instructions for retailer and consumer product return.

==> 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 Amneal Customer Service toll-free at 1-833-582-0812 during normal business hours from 8:00 AM to 5:00 PM Eastern Standard Time, Monday to Friday or by e-mail at AmnealProductRecallDS@amneal.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 Amneal Pharmaceuticals LLC, please search for “Amneal” 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: 13108-2020
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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