Granules Pharma Metformin Hydrochloride Recall [US]


Granules Pharma Metformin Hydrochloride Recall [US]

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US FlagUS/Silver Spring: Granules Pharmaceuticals, Inc., a Chantilly, Virginia establishment, recalls twelve (12) batch/lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 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/dXLm30qX5hG

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/granules-pharmaceuticals-inc-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:

  • Granules Pharmaceuticals Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, sold in 100 count bottles with an NDC of 70010-492-01
  • Granules Pharmaceuticals Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, sold in 500 count bottles with an NDC of 70010-492-05

Please consult the photograph above for details of the drug’s packaging, design and retail/wholesale presentation. Additional information, including batch/lot number and expiry date, are available on the Web site listed above.

==> No barcodes, DINs, NDCs, 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.

Granules’ test results showed NDMA levels above the FDA acceptable limit in one (1) out of the twelve (12) batch/lots distributed to the US market. All other batches continue to remain within the specifications. Out of abundance of caution, however, Granules Pharmaceuticals has decided to recall all twelve (12) of the distributed batch/lots within expiry of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg from the market.

==> Never stop taking your prescription medications, including Metformin Hydrochloride, 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.

==> 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.

==> 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.

The affected Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, lots were distributed nationwide in the USA directly to Distributors, and Retailers. Granules Pharmaceuticals, Inc. is in the process of notifying its distributors and customers affected by this recall via mail (FedEx standard overnight) by mailing a recall notification letter and is arranging for return of the entire recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

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US CDC Coronavirus Tips___________________________________________________________

Customers and patients with medical-related questions, who wish to report an adverse event, or quality issues about the Granules Pharmaceuticals’ products being recalled should contact Inmar Rx Solutions, Inc. toll-free at 1-888-985-9117. Staffed calls are received from 9:00 AM to 5:00 PM Eastern Standard Time, Monday to Friday. For reimbursement, please have the recalled batch/lot returned to Inmar Rx Solutions, Inc. The batch/lot number can be found on the side of the bottle.

==> 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 Granules Pharmaceuticals, please search for “Granules” 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: 13226-2020
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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