Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Lupin recalls 4179 boxes of Tydemy. Tydemy is Drospirenone, Ethinyl Estradiol & Levomefolate Calcium Tablets 3.0/0.03/0.451mg & 0.451mg, 28 tablets in 1 blister and each blister in a pouch. The recall is initiated due to failed impurities and out of specification (OOS) for the inactive content in tablet, ascorbic acid. FDA has not yet classified the recall.
FDA has issued a warning to consumers that Tydemy, a prescription oral contraceptive, may have reduced effectiveness (https://tinyurl.com/Tydemyrecall)
Also Lupin has issued a recall announcement for Tydemy (https://tinyurl.com/LupinTydemy)
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