Viorele birth-control pills are recalled in the United States for failed impurity and degradation specifications. Glenmark Pharmaceuticals Inc. is distributing the issue nationwide, affecting 26,928 packs. Patients should stop using the product and contact a clinician for guidance.
Failed Impurities/Degradation Specifications
Consumers and healthcare providers should stop using this product immediately. Contact Glenmark Pharmaceuticals Inc., USA or your healthcare provider for guidance. Notification method: Letter
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Viorele is a prescription combined oral contraceptive pill used to prevent pregnancy. It is distributed nationwide in the United States.
The recall is due to impurities and degradation specifications. Impurities or degradation products could cause adverse effects or reduced effectiveness.
This recall is not described as part of a broader industry pattern.
Consumers may face treatment delays or require medical guidance if affected; no injuries reported yet.
NDC on label and carton, along with batch and expiration details
Not specified in the recall notice
Keep the recall notification, packaging, and all correspondence with pharmacists or doctors.
Product: Viorele Desogestrel and Ethinyl Estradiol USP 0.15 mg/0.02 mg and Ethinyl Estradiol USP 0.01 mg; Packaging: 3 blisters each containing 28 tablets; Regimen: Rx only, 28-day; NDC: 68462-318-29; Batch: 20230733; Exp: October 2025; Manufacturer: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430; Distribution: US Nationwide; Quantity: 26,928 packs.
No injuries or incidents have been reported.
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