Class II · Moderate risk Ongoing
Alyacen 7/7/7
Reason Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Estarylla
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
What was recalled
Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15
- Recalling firm
- Sandoz Incorporated
- NDC code
- 0781-4058-15
- Origin
- CO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-805-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Estradiol recalls
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Class II · Moderate risk Ongoing
Estradiol Gel
Reason Defective Container; packets were found to be either empty or partially full.
Class II · Moderate risk Ongoing
Estradiol
Reason Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Estradiol
Reason Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Estradiol
Reason Presence of Foreign substance - potential presence of metal particulate matter
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