All 500 mg and 1000 mg doses of Metformin Hydrochloride Extended-Release Tablets made by Lupin Pharmaceuticals were recalled Wednesday. Some batches tested as having more carcinogen NDMA than allowed by FDA standards.
If this sounds familiar, Lupin is the second company to recall the Type 2 diabetes drug this week, following Monday’s recall by Granules Pharmaceuticals. Also, Lupin recalled one lot of metformin in June, the fifth of the five companies the FDA asked to recall its metformin over NDMA content.
This recall covers all 500 mg bottles with NDC No. 68180-338-01 distributed from 11/21/2018 through 05/27/2020 or 68180-336-07, distributed from 11/05/2018 through 05/22/2020; all 1000 mg bottles with NDC No. 68180-339-09 distributed from 11/21/2018 through 05/27/2020 or NDC No. 68180-337-07 distributed from 11/05/2018 through 05/22/2020.
(The NDC number is on the top of the bottle label).
Anyone with this recalled metformin is asked to return it to Inmar Rx Solutions, Inc., 635 Vine St, Winston Salem, NC, 27101. Inmar’s also handling questions about the recall as well as reimbursements at 855-532-1856, Monday through Friday, 9 a.m. to 5 p.m., Eastern time.
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