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.
Caziant
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.
What was recalled
Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA 92880; Distributed by: Watson Pharma, Inc., Corona, CA 92880.
- Recalling firm
- Watson Laboratories Inc
- NDC code
- 52544-959-28
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-094-2013
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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